Curriculum Vitae

University of Washington
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North , M2-C801
PO Box 19024
Seattle , WA 98109
Tel: (206) 667-7299
Fax: (206) 667-4378
e-mail: pgilbert@scharp.org
webpage: http://faculty.washington.edu/peterg

University of Washington , B.S., Mathematics, ----
University of Washington , M.S., Biostatistics, ----
University of Washington , Ph.D., Biostatistics, ----

Postdoctoral Training:

Harvard School of Public Health, Department of Biostatistics, 1997

not applicable

Research Assistant, Department of Mathematics, University of Washington, 1991

Graduate Research Assistant, Coronary Artery Surgery Study, University of Washington, 1992-1993

Graduate Research Assistant, HIVNET, University of Washington, 1995-1996

Research Fellow, Department of Biostatistics, Harvard School of Public Health, 1997

Assistant Professor, Department of Biostatistics, Harvard School of Public Health, 1998-2001

Assistant Member, Fred Hutchinson Cancer Research Center, 2001-2002

Associate Member, Fred Hutchinson Cancer Research Center, 2002-2007

Member, Fred Hutchinson Cancer Research Center, 2007-present

Research Assistant Professor, Department of Biostatistics, University of Washington School of Public Health, 2002-2004

Research Associate Professor, Department of Biostatistics, University of Washington School of Public Health, 2004-present

Deputy Director of Statistical Sciences, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, 2005-2006

Co-Director, Statistical Data Management Center of the HIV Vaccine Trials Network, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, 2004-present

Research Professor, University of Washington, Fred Hutchinson Cancer Research Center, 2008-present

Dean's List, University of Washington, -------

Phi Beta Kappa, ----

Golden Key National Honor Society, ----

B.S., Magna Cum Laude, ----

Honorary Donovan J. Thompson Award for outstanding performance as a student in biostatistics, University of Washington, ----

School of Public Health and Community Medicine Outstanding Student Scholarship, University of Washington, ----

Senior Biostatistics Student Award, University of Washington, ----

Excellent Teaching Rating, each of two semester courses, Harvard School of Public Health, 2000-2001

Ross L. Prentice Professorship at the Department of Biostatistics, University of Washington, 2005-2006

Reviewed AIDS clinical trials grants for the Canadian Institutes of Health Research (CIHR), March and August, 2001

Member of a Technical Evaluation Panel for a Contract Proposal Review for the National Institutes of Health, National Cancer Institute, August, 2002

Lead statistician on the Vax004 Analysis Committee, a committee formed by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, which performed an independent data analysis of the first HIV vaccine efficacy trial, conducted in North America/Netherlands by VaxGen, 2003-2004

Lead statistician on the Vax003 Analysis Team, which performed the analysis of the second HIV vaccine efficacy trial, conducted in Bangkok, Thailand by VaxGen, 2003-2006

Member of the Harvard AIDS Institute research group as a statistician to design and carry out HIV clinical trials in Botswana, and to perform collaborative and methodological HIV research in Senegal and Tanzania, 1997-2006

Member of an HIV Special Emphasis Panel to review grant applications received in response to PAR-03-095: The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD), February 2004

Member of the Gates Foundation Intermittent Preventive Treatment of Infants and Children for Malaria (IPTi) Review Committee, 2004

Member of Safety Monitoring Committee for a Phase II Extended Safety Study of Tenofovir, Centers of Disease Control and Prevention, 2004-present

Member of Safety and Efficacy Monitoring Committee for an AIEDRP/ACTG Phase II trial of Cyclosporine A, Trizivir, and Kaletra in subjects with primary HIV infection, 2005-present

Temporary Member of the NIH AIDS Clinical Studies and Epidemiology Study Section: AIDS and Related Research Integrated Review Group, 2004

Member of the NIH AIDS Clinical Studies and Epidemiology Study Section: AIDS and Related Research Integrated Review Group, 2005-2008

Member of HIV Vaccine Trials Network Protocol Committee, 2007-present

Alternate Member of the Institute of Medicine’s Study on Intermittent Preventive Therapy for Malaria in Infants (IPTi), 2008

Associate Editor, Annals of Applied Statistics, 2006-present

Referee for The American Journal of Epidemiology, The Annals of the Institute of Statistical Mathematics, The Annals of Statistics, Antiviral Therapy, Biometrics, Biometrical Journal, Biometrika, The Canadian Journal of Statistics, Communications in Statistics, Controlled Clinical Trials, Journal of AIDS, Journal of the American Medical Association, Journal of the American Statistical Association, Journal of Human Virology, The Journal of Infectious Diseases, Journal of the Royal Statistical Society B, Journal of Statistical Planning and Inference, The Lancet Infectious Diseases, PLoS Medicine, Nature Medicine, Nonparametric Statistics, Scandinavian Journal of Statistics, Statistica Sinica, Statistics in Medicine

Professional Societies:

American Statistical Association
International Biometric Society

7. Bibliography

1. De Gruttola V, Hughes M, Gilbert P, Phillips A. Trial design in the era of highly effective antiviral drug combinations for HIV-1 infection. AIDS, 1998; 12:S149 – 56.
2. Gilbert P , De Gruttola V, Hammer S. Efficient trial designs for studying combination antiretroviral treatments in patients with various resistance profiles. The Journal of Infectious Diseases, 1998; 178:340 – 348.
3. Gilbert P , Self S, Ashby A. Statistical methods for assessing differential vaccine protection against human immunodeficiency virus types. Biometrics, 1998; 54:799 – 814.
4. Scharfstein D, Tsiatis A, Gilbert P. Semiparametric efficient estimation in the generalized odds-rate class of regression models for right-censored time to event data. Lifetime Data Analysis, 1998; 4:355 – 391.
5. Christie P, Edelberg J, Picard M, Foulkes A, Mamuya W, Weiler-Guettler H, Gilbert P, Rosenberg R. A murine model of myocardial microvascular thrombosis. Journal of Clinical Investigation, 1999; 104:533 – 539.
6. Gilbert P , Lele S, Vardi Y. Maximum likelihood estimation in semiparametric selection bias models with application to AIDS vaccine trials. Biometrika, 1999; 86:27 – 43.
7. Renjifo B, Gilbert P, Chaplin B, Vannberg F, Mwakagile D, Fawzi W, Essex M. Emerging recombinant human immunodeficiency viruses: uneven representation of the V3 loop envelope region. AIDS, 1999; 13:1613 – 1621.
8. Gilbert P . Large sample theory of maximum likelihood estimates in semiparametric biased sampling models. Annals of Statistics, 2000; 28:151-194.
9. Gilbert P . Some statistical issues in the design and analysis of HIV-1 vaccine and treatment trials. Statistical Methods in Medical Research, 2000; 9:207-229.
10. Gilbert P . Comparison of competing risks failure time methods and time-independent methods for assessing strain variations in vaccine protection. Statistics in Medicine, 2000; 19:3065-3086.
11. Gilbert P . Interpretability and robustness of sieve analysis models for assessing HIV-1 strain variations in vaccine efficacy. Statistics in Medicine, 2000; 20:263-279.
12. Gilbert P . Developing an AIDS vaccine by sieving. Chance, 2000; 13:16-21.
13. Gilbert P , Hanna G, De Gruttola V, Martinez-Picado J, Kuritzkes D, Johnson V, Richman D, D'Aquila R. Comparative analysis of HIV-1 type 1 genotypic resistance across antiretroviral trial treatment regimens. AIDS Research and Human Retroviruses, 2000; 16:1325-1336.
14. Gilbert P , Ribaudo H, Greenberg L, Yu G, Bosch R, Tierney C, Kuritzkes D. Considerations in choosing a primary endpoint that measures durability of virological suppression in an antiretroviral trial. AIDS, 2000; 14:1961-1972.
15. Segal S, Su M, Gilbert P. The effect of a rapid change in availability of epidural analgesia on the cesarean delivery rate: A meta-analysis. American Journal of Obstetrics and Gynecology, 2000; 183:974-978.
16. Gilbert P , DeGruttola V, Hammer S, Kuritzkes D. Virological and regimen termination surrogate endpoints in AIDS clinical trials. The Journal of the American Medical Association, 2001; 285:775-782.
17. Gilbert P , Novitsky V, Montano M, Essex M. An efficient test for comparing HIV-1 sequence diversity between populations. The Journal of Computational Biology, 2001; 8:123-139.
18. Gilbert P , Self S, Rao M, Naficy A, Clemens J. Sieve analysis: Methods for assessing how vaccine efficacy depends on genotypic and phenotypic pathogen variation from vaccine trial data. Journal of Clinical Epidemiology, 2001; 54:68-85.
19. Havlir D, Bassett R, Levitan D, Gilbert P, Tebas P, Collier A, Hirsch M, Ignacio C, Condra J, Gunthard H, Richman D, Wong J. Prevalence and predictive value of intermittent viremia with combination HIV-1 therapy. The Journal of the American Medical Association, 2001; 286:171-179.
20. Havlir D, Gilbert P, Bennett K, Collier A, Hirsch M, Tebas P, Adams E, Wheat LJ, Goodwin D, Schnittman S, Holohan MK, Richman D, and the ACTG 5025 Study Team. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS, 2001; 15:1379-1388.
21. McKeague I, Gilbert P, Kanki P. Comparison of competing risks with adjustment for covariate effects. Biometrics, 2001; 57:818-828.
22. Novitsky V, Rybak N, McLane MF, Gilbert P, Chigwedere P, Klein I, Gaolekwe S, Chang SY, Peter T, Thior I, N'dungu T, Vannberg F, Foley BT, Marlink R, Lee TH, Essex M. Identification of human immunodeficiency virus type 1 subtype C Gag-, Tat-, Rev-, and Nef-specific Elispot-based CTL responses for AIDS vaccine design. Journal of Virology, 2001; 75:9210-9228.
23. Novitsky V, Smith UR, Gilbert P, McLane MF, Chigwedere P, Williamson C, Ndung'u T, Klein I, Chang SY, Peter T, Thior I, Foley BT, Gaolekwe S, Rybak N, Gaseitsiwe S, Vannberg F, Marlink R, Lee TH, Essex M. Human Immunodeficiency Virus Type 1 Subtype C molecular phylogeny: Consensus sequence for an AIDS vaccine design? Journal of Virology, 2002; 76:5435-5451.
24. Wu L, Gilbert P. Flexible weighted log-rank tests optimal for detecting early and/or late survival differences. Biometrics, 2002; 58:997-1004.
25. Gilbert P , Wei LJ, Kosorok MR, Clemens JD. Simultaneous inference on the contrast of two hazard functions with censored observations. Biometrics, 2002; 58:773-780.
26. Novitsky V, Cao H, Rybak N, Gilbert P, McLane MF, Gaolekwe S, Peter T, Thior I, N'dungu T, Marlink R, Lee TH, Essex M. Magnitude and frequency of Cytotoxic T-Lymphocyte responses: Identification of immunodominant regions of Human Immunodeficiency Virus Type 1 Subtype C. Journal of Virology, 2002; 76:10155-10168.
27. Mani I, Gilbert P, Sankale J-L, Eisen G, Mboup S, Kanki PJ. Intrapatient diversity and its correlation with viral setpoint in Human Immunodeficiency Virus Type 1 CRF02 A\G-IbNG infection. Journal of Virology, 2002; 76:10745-10755.
28. Weiser S, Wolfe W, Bangsberg D, Thior I, Gilbert P, Makhema J, Kebaabetswe P, Dickenson D, Mompati KF, Marlink R. Barriers to antiretroviral adherence for patients living with HIV and AIDS in Botswana. Journal of the Acquired Immune Deficiency Syndrome, 2003; 34:281-288.
29. Renjifo B, Chung M, Gilbert P, Msamanga G, Mwakagile, Fawzi W, Essex M. In-utero transmission of quasi-species among HIV-1 genotypes. Virology, 2003; 15:278-282.
30. Novitsky V, Gilbert P, Peter T, McLane MF, Gaolekwe S, Rybak N, Thior I, Ndung'u T, Marlink R, Lee TH, Essex M. Association between virus-specific T-cell responses and plasma viral load in HIV-1 subtype C infection. J Virology, 2003; 77:882-890.
31. Montano MA, Russell MS, Gilbert P, Thior I, Lockman S, Shapiro R, Chang SY, Lee TH, Essex M. Comparison of viral load markers for predicting perinatal HIV-1 transmission. Journal of Infectious Diseases, 2003, 188:406-413.
32. Gilbert P . Goodness-of-fit tests for semiparametric biased sampling models with application to AIDS vaccine trials. Journal of Statistical Planning and Inference, 2003; 118:51-81.
33. Gilbert P , McKeague I, Eisen G, Mullins C, Guéye-NDiaye A, M'Boup S, Kanki P. Comparison of HIV-1 and HIV-2 infectivity from a prospective cohort study in Senegal. Statistics in Medicine, 2003; 22:573-593.
34. Gilbert P , Chiu Y-L, Allen M, Chapdu C, Israel H, Holman D, Lawrence D, Keefer MC, Wolff M, Frey SE, and the NIAID HIV Vaccine Trials Network: Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS Vaccine Evaluation Group NIAID-sponsored Phase I and II clinical trials. Vaccine, 2003; 21:2933-2947.
35. Gilbert P , De Gruttola V, Hudgens M, Self S, Hammer S, Corey L. What constitutes efficacy for an HIV vaccine that ameliorates viremia: Issues involving surrogate endpoints in Phase III trials. Journal of Infectious Diseases, 2003; 188:179-193.
36. Gilbert P , Bosch R, Hudgens M. Sensitivity analysis for assessing vaccine effects on viral load in HIV-1 vaccine trials. Biometrics, 2003; 59:531-541.
37. Gilbert P , McKeague I, Sun Y. Tests for comparing mark-specific hazards and cumulative incidence functions. Lifetime Data Analysis, 2004; 10:5-28.
38. Renjifo B, Gilbert P, Chaplin B, Msamanga G, Mwakagile, Fawzi W, Essex M; Tanzanian Vitamin and HIV Study Group. Preferential in-utero transmission of HIV-1 subtype C as compared to HIV-1 subtype A or D. AIDS, 2004; 18:1629-1636.
39. Hudgens M, Gilbert P, Self S. Endpoints in vaccine trials. Statistical Methods in Medical Research, 2004; 13:89-114.
40. Evans TG, Frey S, Israel H, Chiu J, El-Habib R, Gilbert P, Gaitan A, Montefiori DC, and the HIV Vaccine Trials Network (HVTN 803). Long-term memory B-cell responses in recipients of candidate human immunodeficiency virus type 1 vaccines. Vaccine, 2004; 22:2626-2630.
41. Lee D, Graham BS, Chiu Y-L, Gilbert P, McElrath MJ, Belshe RB, Buchbinder SP, Sheppard HW, Koblin BA, Mayer KH, Keefer MC, Mulligan MJ, Celum CL. Breakthrough infections during phase I-II prime-boost HIV vaccine trials with canarypox vectors (ALVAC TM) and recombinant gp120 or gp160. Journal of Infectious Diseases , 2004; 190:903-907.
42. Huang C, Barreda P, Mendoza V, Saavedra JM, Guzman L, Gilbert P. A comparative analysis of abandoned street children and formerly abandoned street children in La Paz, Bolivia. Archives ofDiseases in Childhood, 2004; 89:821-826.
43. Gilbert P , Rossini AJ, Shankarappa R. Two-sample tests for comparing intra-individual genetic sequence diversity between populations. Biometrics, 2005; 61:107-118.
44. Gilbert P . A modified false discovery rate multiple comparisons procedure for discrete data, with application to HIV genetics. Applied Statistics, 2005; 54;143-158.
45. rgp120 HIV Vaccine Study Group*. Placebo-controlled trial of a recombinant glycoprotein 120 vaccine to prevent HIV infection. Journal of Infectious Diseases, 2005; 191:654-665. [*P Gilbert the senior biostatistician for this clinical trial]
46. Gilbert P , Peterson M, Follmann D, Francis D, Gurwith M, Heyward W, Hudgens M, Jobes D, Popovic V, Self S, Sinangil F, Burke D, Berman P. Immunologic responses to rgp120 vaccine correlate with the incidence of HIV-1 infection in a Phase 3 preventive HIV-1 vaccine trial. Journal of Infectious Diseases, 2005; 191:666-677.
47. Gilbert P , Sun Y. Failure time analysis of HIV vaccine effects on viral load and antiretroviral therapy initiation. Biostatistics, 2005; 6:374-394.
48. Mascola JR, D’Souza P, Gilbert P, Hahn BH, Haigwood NL, Morris L, Petropoulos CJ, Polonis VR, Sarzotti M, Montefiori DM. Recommendations for the design and use of standard virus panels to assess neutralizing antibody responses elicited by candidate Human Immunodeficiency Virus Type 1 vaccines, Journal of Virology, 2005; 79:10103-10107.
49. Li M, Gao F, Mascola JR, Stamatatos L, Polonis VR, Koutsoukos M, Voss G, Goepfert P, Gilbert P, Greene KM, Bilska M, Kothe DL, Salazar-Gonzalez JF, Wei X, Decker JM, Hahn BH, Montefiori DC. Human Immunodeficiency Virus Type 1 env clones from acute and early subtype B infections for standardized assessments of vaccine-elicited neutralizing antibodies, Journal of Virology, 2005; 79:10108-10125.
50. Meier A, Gilbert P. Issues in timing of data collection for estimating treatment effects in randomized clinical trials. Contemporary Clinical Trials, 2005; 26:598-610.
51. Gilbert P , Novitsky V, Essex M. Covariability of southern African HIV-1 subtype C amino acids. AIDS Research and Human Retroviruses, 2005; 21:1016-1030.
52. Gilbert P , Ackers M, Berman P, Francis D, Popovic V, Hu D, Heyward W, Sinangil F, Shepherd B, Gurwith M. HIV-1 virologic and immunologic progression and antiretroviral therapy initiation among HIV-1 infected participants in an efficacy trial of a recombinant glycoprotein 120 vaccine. Journal of Infectious Diseases, 2005; 192:974-983 .
53. Wick WD, Gilbert P, Self SG. On modeling HIV and T cells in vivo: Assessing causal estimators in vaccine trials. PLoS Computational Biology, 2006; 6: e64. DOI: 10.1371/journal.pcbi.0020064.
54. Shepherd B*, Gilbert P, Jemiai Y, Rotnitzky A. Sensitivity analyses comparing outcomes only existing in a subset selected post-randomization, conditional on covariates, with application to HIV vaccine trials. Biometrics, 2006; 62:332-342. [* University of Washington PhD student of P Gilbert]
55. Ndung'u T, Sepako E, McLane M, Chand F, Bedi K, Gaseitsiwe S, Doualla-Bell F, Peter T, Thior I, Moyo S, Gilbert P, Novitsky V, Essex M. HIV-1 subtype C in vitro growth and co-receptor utilization. Virology, 2006; 347:247-260.
56. Moodie Z, Rossini A, Hudgens M, Gilbert P, Self S, Russell N. Statistical evaluation of HIV vaccines in early clinical trials. Contemporary Clinical Trials, 2006; 27:147-160.
57. Novitsky V, Gilbert P, Shea K, McLane MF, Rybak N, Klein I, Thior I, Ndung’u T, Lee TH, Essex M. Interactive association of proviral load and IFN-γ–secreting T cell responses in HIV-1C infection. Virology, 2006; 349:142-155.
58. Shapiro RL, Thior I, Gilbert P*, Lockman S, Wester C, Smeaton LM, Stevens L, Heymann JS, Ndung’u T, Gaseitswe S, Novitsky V, Makhema J, Lagakos S, Essex M, and the Mashi Study Team. Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother-to-child HIV transmission in Botswana. AIDS, 2006; 20:1281-1288. [*P Gilbert the senior biostatistician (with Steve Lagakos) for this clinical trial]
59. Thior I, Lockman, S, Smeaton L, Shapiro RL, Wester C, Jeymann JS, Gilbert P*, Stevens L, Peter T, Kim S, van Widenfelt E, Moffat C, Ndase P, Arimi P, Poloko K, Mazonde P, Makhema H, McIntosh K, Novitsky V, Lee T-H, Marlink R, Lagakos S, Essex M for the Mashi Study Team. Breastfeeding plus 6 months of infant Zidovudine prophylaxis vs formula feeding plus infant Zidovudine for 1 month to reduce HIV transmission in Botswana. A randomized trial: The Mashi Study. Journal of the American Medical Assocation 2006; 296:794-805. [*P Gilbert the senior biostatistician (with Steve Lagakos) for this clinical trial]
60. Mehrotra D, Li X, Gilbert P. A comparison of eight methods for the dual-endpoint evaluation of efficacy in a proof-of-concept HIV vaccine trial. Biometrics, 2006; 62:893-900.
61. Cai T, Gilbert P, Self S. Joint inferences on vaccine efficacy against infection and disease, with application to the first HIV vaccine efficacy trial. Journal of Biopharmaceutical Statistics, 2006; 16:517-538.
62. Li F, Malhotra U, Gilbert P , Hawkins N, Duerr A, McElrath J, Corey L, Self S. Peptide selection for human immunodeficiency virus type 1 CTL-based vaccine evaluation. Vaccine, 2006; 24:6893-6904.
63. Li F, Gilbert P, Self S. Identification of cross-neutralization determinants by GAP analysis: A mutational behavior approach. Current HIV Research, 2007; 5:85-94.
64. Li F, Horton H, Gilbert P, McElrath J, Corey L, Self S. HIV-1 CTL-based vaccine immunogen selection: Antigen diversity and cellular response features. Current HIV Research, 2007; 5:95-105.
65. Shepherd B*, Gilbert P, Mehrotra D. Eliciting a counterfactual sensitivity parameter. The American Statistician, 2006, 61: 56-63. [* University of Washington PhD student of P Gilbert]
66. Pitisuttithum P, Gilbert P*, Gurwith M, Heyward W, Martin M, van Griensven F, Hu D, Tapperio JW; Bangkok Vaccine Evaluation Group. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. Journal of Infectious Diseases, 2006; 194:1661-1671. [*P Gilbert the senior biostatistician for this clinical trial]
67. Hudgens MG, Maathuis MH, Gilbert P. Nonparametric estimation of the joint distribution of a survival time subject to interval censoring and a continuous mark variable. Biometrics, 2007; OnLineEarly Articles. doi:10.1111/j.1541-0420.2006.00709.x.
68. Follmann D, Duerr A, Tabet S, Gilbert P, Moodie Z, Fast, P, Cardinali M, Self S, for the Workshop participants. Endpoints and regulatory issues in HIV vaccine clinical trials: Lessons from a workshop. Journal of Acquired Immune Deficiency Syndrome, 2007; 44:49-60.
69. Nickle D, Heath L, Jensen M, Gilbert P, Mullins J, Pond S. HIV-specific probabilistic models of protein evolution. PLoS ONE, 2007 June 6;2:e503.
70. Forthal D, Gilbert P, Landucci G, Phan T. Recombinant gp120 vaccine-induced antibodies inhibit clinical strains of HIV-1 in the presence of Fc receptor-bearing effector cells and correlate inversely with HIV infection rate. Journal of Immunology, 2007, 178:6596-6603.
71. Qin L, Gilbert P, Corey L, McElrath J, Self S. A framework for assessing immunological correlates of protection in vaccine trials. The Journal of Infectious Diseases, 2007, 196: 1304-1312.
72. Shepherd B*, Gilbert P, Lumley T. Sensitivity analyses comparing time-to-event outcomes only existing in a subset selected post-randomization, conditional on covariates, with application to HIV vaccine trials. Journal of the American Statistical Association, 2007; 102:573-582. [* University of Washington PhD student of P Gilbert]
73. Jemiai Y, Rotnitzky A, Shepherd B*, Gilbert P. Semiparametric estimation of treatment effects on an outcome existing only if a post-randomization event occurs. Journal of the Royal Statistical Society Series B, 2007; 69:879-902. [* University of Washington PhD student of P Gilbert]

In Press

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Manuscripts Under Review

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b) Other refereed scholarly publications

Not applicable

c) Books and book chapters

1. Gilbert P and Esparza J. HIV-1 vaccine testing, trial design, and ethics. In: AIDS in Africa, Second Edition, Editors M. Essex, S. M'Boup, P. Kanki, R. Marlink, S. Tlou, 2002. Kluwer Academic, New York.
2. Gilbert P and Sun Y. Simultaneous inferences of HIV vaccine effects on viral load, CD4 cell counts, and antiretroviral therapy initiation in Phase 3 trials. In: Deterministic and Stochastic Models of HIV with Intervention, Editors W.-Y. Tan and H. Wu, 2004.

d) Other non-refereed published scholarly publications

1. Gilbert P and Bosch R. Applications of semiparametric biased sampling models to AIDS vaccine and treatment trials. Probability Theory and Mathematical Statistics, Proceedings of the 7th Vilnius Conference on Probability Theory and Mathematical Statistics, published by VSP, Utrecht, the Netherlands and TEV, Vilnius, Lithuania, 1999.

8. Patents and Other Intellectual Property

Not applicable

9. Funding History

a) Funded projects

NIH-NIAID, Grant 2 U01 AI46703-06, HIV Vaccine Trials Network Leadership Group,

NIH-NIAID, Grant 1 RO1 AI054165-01, “Statistical Methods in HIV Vaccine Efficacy Trials”,

NIH-NIAID, Grant 2 RO1 AI054165-04, “Statistical Methods in HIV Vaccine Efficacy Trials”,

NIH/NIAID (Sub-award from Duke University), Statistical Data Management Center for the Center for HIV/AIDS Vaccine Immunology (CHAVI), 1 U01 AI067854 (Haynes)

Bill & Melinda Gates Foundation, Vaccine Immunology Statistical Center (VISC),

b) Pending Applications

Not Applicable

10. Public Health Practice Activities

Not applicable

11. Conferences and Symposiums

1. Mayers D, Gilbert P, Merigan T for the ACTG244/RV79 Study Team. T215Y/F mutation associated with zidovudine resistance leads to poor response to ZDV+ddI or ZDV+ddI+NVP: ACTG244/RV79. In: Program and abstracts of the Sixth Conference on Retroviruses and Opportunistic Infections, 1999, Abstract 129.
2. Havlir D, Gilbert P, Bennett K, Collier A, Hirsch M, Tebas P, Adams E, Holohan MK, Richman D and the ACTG 5025 Study Team. Randomized trial of continued Indinavir (IDV)/ZDV/3TC versus switch to IDV/ddI/d4T or IDV/ddI/d4T+hydroxyurea in patients with viral suppression. In: Program and abstracts of the Seventh Conference on Retroviruses and Opportunistic Infections, San Francisco, California, 2000.
3. Havlir D, Levitan D, Bassett R, Gilbert P, Richman D, Wong J. Prevalence and predictive value of intermittent viremia in patients with viral suppression. In: Program and abstracts of the Fourth International Workshop on HIV-1 Drug Resistance and Treatment Strategies, Spain, 2000.
4. Novitsky V, Rybak N, Gilbert P, Gaolekwe S, Peter T, McLane MF, Thior I, Lee TH, Ndung’u T, Marlink R, Essex M. Magnitude and frequency of CTL responses to HIV-1 subtype C. In: Program and abstracts of the Fourteenth International AIDS Conference, Barcelona, Spain, 2002.
5. Renjifo B, Tanzania Vitamin and HIV Study Group, Gilbert P, Chaplin B, Msamanga G, Mwakagile, Fawzi W, Essex M. Preferential in-utero transmission of HIV-1 subtype C compared to subtype A or D. In: Program and abstracts of the Fourteenth International AIDS Conference, Barcelona, Spain, 2002.
6. Gilbert P. De Gruttola V, Hudgens M, Self S, Hammer S, Corey L. What constitutes effectiveness for an HIV vaccine that ameliorates viremia: Issues involving surrogate endpoints in efficacy trials. In: Abstracts of the 10 th Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts, Abstract 84, February 2003.
7. Gilbert P , Popovic V, Gurwith M, Francis D. Immunologic responses to rgp-120 vaccine and correlation with the risk of HIV infection- results from the world’s first HIV vaccine efficacy trial. In: Program and abstracts of AIDS Vaccine 2003, New York, New York, 2003.
8. Popovic V, Gurwith M, Francis D, Heyward W, Berman P, Gilbert P. Evaluation of vaccine efficacy in populations with high risk behavior and high HIV incidence-results from the world’s first Phase III trial of HIV vaccine. In: Program and abstracts of AIDS Vaccine 2003, New York, New York, 2003.
9. Popovic V, Gurwith M, Francis D, Harro C, Mayer KH, Heyward W, Berman P, Gilbert P. Differential efficacy in prevention of HIV infection by rgp120 HIV-1 vaccine by gender and race – is it real? In: Program and abstracts of AIDS Vaccine 2003, New York, New York, 2003.
10. Djomand G, Gilbert P, Chiu Y-L, Malone S, Sullivan P, Russell N, Hammer S, Celum C, Wasserheit J. Incidence of HIV-1 breakthrough infection among participants enrolled in HIV vaccine trials from 1988 to 2002. In: Program and abstracts of AIDS Vaccine 2003, New York, New York, 2003.
11. Djomand G, Gilbert P, Chiu Y-L, Malone S, Sullivan P, Russell N, Hammer S, Celum C. Incidence of HIV-1 breakthrough infection among participants enrolled in HIV vaccine trials from 1988 to 2002. In: Program and abstracts of the Second International AIDS Society Conference on HIV Pathogenesis and Treatment, Paris, France, 2003.
12. Follmann D, Gilbert P, Self S, Hudgens M, Gurwith M, Popovic V, Ackers M, Hu D, Flores J. An independent analysis of the effect of race in VAX004. In: Program and abstracts of the Eleventh Conference on Retroviruses and Opportunistic Infections, San Francisco, 2004, Abstract 106.
13. Shapiro R, Thior I, Gilbert P , Lockman S, Wester C, Smeaton L, Stevens L, Ndung’u T, Novitsky V, van Widenfelt E, Mazonde P, Lee TH, Marlink R, Lagakos S, Essex M, and the Mashi Study Group. Maternal single-dose Nevirapine may not be needed to reduce mother-to-child transmission in the setting of maternal and infant Zidovudine and infant single-dose Nevirapine: Results of a randomized clinical trial in Botswana. In: Program and abstracts of the Twelfth Conference on Retroviruses and Opportunistic Infections, Boston, 2005, Abstract 74LB.
14. Thior I, Lockman S, Smeaton L, Shapiro R, Wester C, Heymann J, Gilbert P , Stevens L, Peter T, Kim S, Makhema J, McIntosh K, Marlink R, Lagakos S, Essex M, and the Mashi Study Team. Breast-feeding with 6 months of infant Zidovudine prophylaxis vs formula-feeding for reducing post-natal HIV transmission and infant mortality: A randomized trial in Southern Africa. In: Program and abstracts of the Twelfth Conference on Retroviruses and Opportunistic Infections, Boston, 2005.
15. Frey SE, Peiperl L, Baden L, McElrath J, Wright P, Goepfert P, Keefer M, Blattner W, Harro C, Hammer S, Baglyos L, Guillet J-G, Gilbert P, Deers M, Elizaga M, Corey L, and the HIV Vaccine Trials Network. Safety of ANRS LIPO-5 alone, sanofi-pasteur ALVAC-HIV (vCP1452) alone, and ALVAC HIV prime/LIPO-5 boost in healthy, HIV-1 uninfected adult participants. In: Program and abstracts of AIDS Vaccine 2005, Montreal, Canada, 2005.
16. Frey SE, Peiperl L, Baden L, McElrath J, Wright P, Goepfert P, Keefer M, Blattner W, Harro C, Hammer S, Hural J, Tomaras G, Baglyos L, Guillet J-G, Gilbert P, Deers M, Elizaga M, Russell N, Corey L, and the HIV Vaccine Trials Network. Immunogenicity of ANRS LIPO-5 alone, sanofi-pasteur ALVAC-HIV (vCP1452) alone, and ALVAC HIV prime/LIPO-5 boost in healthy, HIV-1 uninfected adult participants. In: Program and Abstracts of AIDS Vaccine 2006, Amsterdam, The Netherlands, 2006.
17. Forthal D, Landucci G, Phan T, Higa-Tanner R, Gilbert P . Fc g receptor IIa and IIIa polymorphisms are associated with risk of HIV infection. In: Program and abstracts of the Thirteenth Conference on Retroviruses and Opportunistic Infections, Denver, 2006.
18. Burke D, Karim SSA, Russel N, Wecker M, Allen M, Ferarri G, Gilbert P, Chulay J. (2006). Safety and Immunogenicity of an Alphavirus Replicon HIV Gag Vaccine (AVX101) in Healthy HIV-uninfected Adults. In: Program and Abstracts of AIDS Vaccine 2006, Amsterdam, The Netherlands, 2006.
19. Mehrotra D, Gilbert P, Li X, Heyse J, Buchbinder S, Self S, Robertson M. (2007). A Prototype Test-of-Concept Efficacy Trial Design for Cell Mediated Immunity-Based Vaccines. In: Program and Abstracts of AIDS Vaccine 2007 , Seattle, 2007.
20. Jones N, Gilbert P, de Camp A, Peterson M, Gurwith M, Cao H. AIDSVAX immunization induces HIV-specific CD8+T cell responses in high-risk HIV negative volunteers who subsequently acquire HIV infection. In: Program and Abstracts of AIDS Vaccine 2007 , Seattle, 2007.

Meeting Posters

1. Gilbert P . Methods for comparing genotypic resistance across antiretroviral trial treatment regimens from sequence data in virologic failures only. In: AIDS Clinical Trials Group Meeting, Washington D.C., 1998.
2. Gilbert P . Assessing genotypic resistance in antiretroviral trials using sequence data only from virologic failures. In: Fifth Annual HIV-1 Dynamics and Evolution Meeting, Santa Fe, New Mexico, 1998.
3. Novitsky V, Rybak N, McLane MF, Gilbert P, Chigwedere P, Klein I, Gaolekwe S, Chang SY, Peter T, Thior I, N'dungu T, Vannberg F, Foley BT, Marlink R, Lee TH, Essex M. Predominant HIV-1C-specific CTL responses. In: Program and abstracts of AIDS Vaccine 2001, Philadelphia, Pennsylvania, 2001.
4. Rossini AJ, Self SG, Hudgens M, Gilbert P. Rational approach for HVTN Phase I/II HIV-1 vaccine trials. In: Program and abstracts of AIDS Vaccine 2001, Philadelphia, Pennsylvania, 2001.
5. Chung M, Renjifo B, Gilbert P, Msamanga G, Mwakagile, Fawzi W, Essex M. In-utero transmission of quasi-species among HIV-1 subtypes. In: Program and abstracts of the Fourteenth International AIDS Conference, Barcelona, Spain, 2002.
7. Gilbert P , Self S, DeGruttola V, Hudgens M, Hammer S. Interpreting observed vaccine effects on post infection surrogate endpoints in preventive HIV vaccine efficacy trials. In: Program and abstracts of the Fourteenth International AIDS Conference, Barcelona, Spain, 2002.
8. Novitsky V, Gilbert P, Peter T, Lee TH, Essex M. Viral load, viral diversity, and T-cell immune responses in HIV-1C infection: Implications for vaccine design. Abstracts of the 10 th Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts, Abstract 458, February 2003. Novitsky V, Gilbert P, Ndung’u T, Peter T, Thior I, Lee TH, Essex M. Virus-host interactions in HIV-1C infection. In: Program and abstracts of The Fourteenth International AIDS Conference, Bangok, Thailand, 2004.
9. Malone S, Djomand G, Critchlow C, Gilbert P, Chiu Y-L. Risk of HIV Infection among HIV Vaccine and Placebo Control Recipients Enrolled in NIAID-funded Network HIV Vaccine Trials in the United States, 1988-2002. In: Program and abstracts of The Fourteenth International AIDS Conference , Bangok, Thailand, 2004.
10. Gilbert P , Cai T, Self S, Gurwith M. Joint assessment of HIV vaccine effects on preventing infection and delaying disease in the Phase III trial of AIDSVAX B/B . In: Program and abstracts of the Eleventh Conference on Retroviruses and Opportunistic Infections, San Franciso, 2004, Abstract 283.
11. Shepherd B, Gilbert P, Gurwith M, Francis D. Assessment of HIV vaccine effects on viral load in the Phase III trial of AIDSVAX B/B. In: Program and abstracts of the Eleventh Conference on Retroviruses and Opportunistic Infections, San Francisco, 2004, Abstract 284.

Selected Oral Presentations

1. Gilbert, P . “Sieve Analysis: Statistical methods for assessing differential protection of an HIV-1 vaccine.” DIMACS International Conference on HIV-1 Sequence Variation and Statistical Methods, Rutgers University, New Brunswick, New Jersey, May 1995.
2. Gilbert, P . “Sieve Analysis: Statistical methods for assessing differential protection of an HIV-1 vaccine.” Biostatistics Departmental Seminar, University of California at Los Angeles, Los Angeles, California, February 1996.
3. Gilbert, P .“Sieve Analysis: Statistical methods for assessing differential protection of an HIV-1 vaccine,” Division of Statistics Seminar, University of California at Davis, Davis, California, February 1996.
4. Gilbert, P . “Sieve Analysis: Statistical methods for assessing differential protection of an HIV-1 vaccine,'' Biostatistics Departmental Seminar, University of Wisconsin, Madison, Wisconsin, March 1996.
5. Gilbert, P . “Maximum likelihood estimation in semiparametric selection bias models with application to AIDS vaccine trials,” Biostatistics Departmental Seminar, University of Rochester, Rochester, New York, March 1996.
6. Gilbert, P . “Sieve Analysis: Statistical methods for assessing differential protection of an HIV-1 vaccine.” Biostatistics Departmental Seminar, Harvard University, March 1996.
7. Gilbert, P . “Sieve Analysis: Statistical methods for assessing differential protection of an HIV-1 vaccine.'' Statistics Departmental Seminar, Stanford University, March 1996.
8. Gilbert, P . “Sieve Analysis: Statistical methods for assessing differential protection of an HIV-1 Vaccine,” Biostatistics Departmental Seminar, University of Washington, Seattle, Washington, April 1996.
9. Gilbert, P . “Statistical Issues in Assessing Secondary Endpoints in HIV-1 Vaccine Trials,” HIV-1 Vaccines for Developing Countries: Design of Efficacy Trials, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Dedham, Massachusetts, October 1996.
10. Gilbert, P . “Maximum likelihood estimation in semiparametric selection bias models with application to AIDS vaccine trials,” Statistics Departmental Seminar, Rutgers University, January 1997.
11. Gilbert, P . “Sieve Analysis: Statistical methods for assessing differential vaccine protection against HIV-1 types,” ENAR, session Statistical Methods in HIV-1 Genomic Research and HIV-1 Vaccines, organized by Francoise Seillier-Moiseiwitsch, Memphis, Tennessee, March 1997.
12. Gilbert, P . “Maximum likelihood estimation in semiparametric selection bias models with application to AIDS vaccine trials,” Biostatistics Departmental Seminar, Johns Hopkins University, Baltimore, Maryland, May 1997.
13. Gilbert, P . “Sieve analysis: statistical methods for assessing type-specific vaccine protection from vaccine trial data,” Epidemiology and Statistics Division, National Institute of Child Health and Human Development, Rockville, Maryland, November 1997.
14. Gilbert, P . “Preventive HIV-1 Vaccine Efficacy Trial Design,” International Conference, HIV-1 Vaccines in Thailand: Current Progress 1998. Co-sponsored by the Harvard AIDS Institute, UNAIDS, AIDS Division of the Department of Communicable Disease Control of the Thailand Ministry of Public Health; Asean Institute for Health Development; and Center for Vaccine Development of Mahidol University, Bangkok, Thailand, February 1998.
15. Gilbert, P . “Design and analysis issues for assessing viral and immune correlates of vaccine protection,” HIV-1 Vaccines for developing countries: Immune Correlates of Protection, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Dedham, Massachusetts, April 1998.
16. Gilbert, P . “Applications of semiparametric biased sampling models to AIDS vaccine and treatment trials,” 22nd European Meeting of Statisticians; 7th Vilnius Conference on Probability Theory and Mathematical Statistics, Session on Semiparametric Models, organized by Susan Murphy, Vilnius, Lithuania, August 1998.
17. Gilbert, P . “Empirical processes and semiparametric biased sampling models,” Empirical Processes in Non- and Semiparametric Statistics, Humboldt University, Berlin, Germany, August-September 1998.
18. Gilbert, P . “Empirical processes and semiparametric biased sampling models,” Statistics Departmental Seminar, Yale University, New Haven, Connecticut, September 1998.
19. Gilbert, P . “Two randomized trial designs for studying HIV-1 vaccines in infants,” HIV-1 Vaccines for Developing Countries: Vaccinating Against the Leading Infectious Killers in Children, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Dakar, Senegal, December 1998.
20. Gilbert, P . “Sieve analysis,” VaxGen Incorporated, Brisbane, California, April 1999.
21. Gilbert, P . “Strain selection for HIV-1 vaccine design,” HIV-1 Vaccines for Developing Countries: Prioritizing Vaccine Candidates for Human Trials, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Dedham, Massachusetts, October 1999.
22. Gilbert, P . “Scientific issues in preventive HIV-1 vaccine efficacy trials,” Second National Conference on HIV-1 and AIDS in Botswana, Gaborone, Botswana, February 2000.
23. Gilbert, P . (2000, May 3) “Comparison of HIV-1 and HIV-2 infectivity from a prospective cohort study in Senegal,” Fred Hutchinson Cancer Research Center, Seattle, Washington, May 2000.
24. Gilbert, P . “Comparison of HIV-1 and HIV-2 infectivity from a prospective cohort study in Senegal,” International Biometrics Society Meeting, San Francisco, California, July 2000.
25. Gilbert, P . “Comparison of HIV-1 and HIV-2 infectivity from a prospective cohort study in Senegal,” Statistics Departmental Seminar, University of British Columbia, Vancouver, Canada, November 2000.
26. Gilbert, P . “Scientific issues in preventive HIV-1 vaccine efficacy trials,” HIV-1 Vaccines for Developing Countries: Vaccines for Southern Africa, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Arusha, Tanzania, December 2000.
27. Gilbert, P .“Issues in primary endpoint selection in AIDS clinical trials,” U.S. FDA Meeting on Endpoints for AIDS Clinical Trials, Division of AIDS, Rockville, Maryland, February 2001.
28. Gilbert, P . “Sieve analysis,” Harvard AIDS Institute Seminar, Harvard School of Public Health, Boston, Massachusetts, June 2001.
29. Gilbert, P. “Data management in HIV-1 vaccine trials,” HIV-1 Vaccines for Developing Countries: Establishing networks for HIV-1 trials in Southern Africa, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Gaborone, Botswana, November 2001.
30. Gilbert, P . “Monitoring of HIV-1 vaccine efficacy trials,” HIV-1 Vaccines for Developing Countries: Establishing networks for HIV-1 trials in Southern Africa, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Gaborone, Botswana, November 2001.
31. Gilbert, P . “Assessing HIV vaccine effects on viral load in preventive vaccine efficacy trials,” Biostatistics Departmental Seminar, University of Washington School of Public Health, Seattle, Washington, May 2002.
32. Gilbert, P . “Data management for clinical trials,” HIV-1 Vaccines for Developing Countries: Prospects for an HIV-1 Vaccine for West Africa, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Abuja, Nigeria, February 2003.
33. Gilbert, P . “Methods for comparing mark-specific hazards and cumulative incidence functions between two groups, with application to HIV vaccine trials,” International Conference on Reliability and Survival Analysis, University of South Carolina, Columbia, South Carolina, May 2003.
34. Gilbert, P . “Methods for comparing mark-specific hazards and cumulative incidence functions between two groups, with application to HIV vaccine trials,” Biostatistics Departmental Seminar, University of Washington School of Public Health, Seattle, Washington, June 2003.
35. Gilbert P , Shepherd B. (2004, January 27). “Sensitivity analyses comparing outcomes measured only in a subset selected post-randomization, with application to HIV vaccine trials,” Genentech, San Francisco, California.
36. Gilbert P , Shepherd B. (2004, January 28). “Sensitivity analyses comparing outcomes measured only in a subset selected post-randomization, with application to HIV vaccine trials,” Department of Biostatistics, University of California San Francisco, San Francisco, California.
37. Gilbert P (2004, April 26). “Analysis of post-infection vaccine effects in VaxGen’s two Phase 3 trials,” Workshop on End Points and Regulatory Issues in HIV Vaccines and Clinical Trials, Rockville, Maryland.
38. Gilbert P (2004, May 1). “Surrogate and clinical endpoints for HIV vaccine efficacy trials,” HIV-1 Vaccines for Developing Countries: Initiation of Vaccine Trials in Africa, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Gaborone, Botswana.
39. Gilbert P (2004, May 1). “Moving up the ladder in HIV vaccine trials,” HIV-1 Vaccines for Developing Countries: Initiation of Vaccine Trials in Africa, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Gaborone, Botswana.
40. Gilbert P (2004, June 3). “Inferring dependency of HIV vaccine efficacy on HIV distance,” Schering-Plough Symposium, Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts.
41. Gilbert P (2004, September 13). “Endpoints and analytics for Phase IIb/III HIV vaccine trials,” Meeting of the External Advisory Panel on the Scientific Agenda of the HVTN, Bethesda, Maryland.
42. Gilbert P , Shepherd B, Jemiai Y, Rotnitzky A (2005, August 9). “Sensitivity analysis comparing outcomes measured only in a subset selected post-randomization,” Joint Statistical Meetings, Minneapolis, Minnesota.
43. Gilbert P , Hudgens M (2005, October 14). “ Comparison of group testing algorithms for identifying acute HIV-1 infections ,” Acute HIV-1 Infection, Harvard AIDS Institute Symposium Series on Vaccine Solutions for Developing Countries, Nairobi, Kenya.
44. Forthal D, Gilbert P (2005, November 9). “Role of Fc g RIIa and Fc g RIIIa genotype in risk of HIV infection and VEs,” HIV Vaccine Trials Network Group Meeting, Seattle, Washington.
45. Gilbert P , Hudgens M (2006, May 31). “Evaluating causal effect predictiveness of candidate surrogate endpoints,” Prentice Professorship Lecture, Fred Hutchinson Cancer Research Center, Seattle, Washington.
46. Gilbert P , Hudgens M (2006, August 8). “Evaluating causal effect predictiveness of candidate surrogate endpoints,” Joint Statistical Meetings, Seattle, Washington.
47. Hudgens M, Gilbert P (2006, August 7). “Statistical methods for assessing HIV vaccine efficacy in repeated low-dose challenge experiments,” Joint Statistical Meetings, Seattle, Washington.
48. Huang Y, Gilbert P , Self S (2006, August 9). “Design and analysis of neutralizing antibody assays in HIV-1 vaccine trials,” Joint Statistical Meetings, Seattle, Washington.
49. deCamp A, Gilbert P (2006, August 9). “Antigen scanning methods for identifying peptide signatures,” Joint Statistical Meetings, Seattle, Washington.
50. Gilbert P , Qin L, Self S (2006, October 10). “A framework for evaluating immunological correlates of protection in vaccine trials,” NIH/NIAID Workshop on Statistical Methods in HIV/AIDS and its Practical Application, Bethesda, Maryland.
51. Gilbert P , Qin L, Self S (2006, October 20). “Evaluating immunological correlates of protection,” HIV Vaccine Trials Network Group Meeting, Seattle, Washington.
52. Gilbert P , Hudgens M (2007, March 6). “Evaluating causal effect predictiveness of surrogate endpoints, with application to HIV vaccine trials,” UCLA Biostatistics Departmental Seminar, Los Angeles, California.
53. Hudgens M, Maathuis M, Gilbert P (2007, March 12). “Nonparametric estimation of the joint distribution of a survival time subject to interval censoring and a continuous mark variable,” International Biometric Society ENAR Spring Meeting, Atlanta, Georgia.
54. Gilbert P (2007, July 16). “Sieve Analysis in HIV Vaccine Trials,” First Vaccine Infectious Disease Institute Symposium, Seattle WA.
55. Gilbert P (2007, July 31). “Sieve Analysis for PAVE-100: Toward a Statistical Analysis Plan,” PAVE 100 Viral and Host Genetics Workshop, Vaccine Research Center, NIH, Bethesda, MD.
56. Gilbert P , McKeague I, Sun Y (2007, August 24). “Evaluating Dependency of HIV Vaccine Efficacy on Viral Genetics via Mark-Specific Hazard Function Modeling,” Fred Hutchinson Cancer Research Center, Seattle, WA.
57. Gilbert P (2007, August 28). “Molecular Signatures of Acutely Infecting Viruses,” Second International Conference on HIV Transmission, Washington, DC.
58. Gilbert P (2007, September 5). “Overview of Correlates and Surrogates,” World Health Organization workshop on HIV vaccine trial endpoints. Agence Nationale de Recherches dur le Sida (ANRS), Paris.
59. Gilbert P , Self S, Mehrotra D, Duerr A (2007, November 7). “Longer-term Follow-up of STEP Study Volunteers,”HIV Vaccine Trials Network Group Meeting, Seattle, Washington.
60. Gilbert P (2007, December 6). “Evaluating Immunological Correlates of Protection,” Center for AIDS Research Seminar, University of Washington, Seattle.

12. University Service

Member, Center for Biostatistics in AIDS Research Statistical Computing Committee, Harvard, School of Public Health, 1998-1999

Member, Department of Biostatistics Student Advising Committee, Harvard School of Public Health, 1998-1999

Member, Department of Biostatistics Committee for a Master of Science in Applied Biostatistics, Harvard School of Public Health, 1998-1999

Member, Department of Biostatistics Admissions and Recruiting Committee, Harvard School of Public Health, 1999-2000

Member, Department of Biostatistics Curriculum Committee, Harvard School of Public Health, 1999-2000

Member, Department of Biostatistics Postdoctoral Committee, Harvard School of Public Health, 1999-2000

Member, Department of Biostatistics Committee for the Summer Program in Biostatistics for Underrepresented Minority Groups, Harvard School of Public Health, 1999-2001

Member, Department of Biostatistics Diversity Committee, Harvard School of Public Health, 1999-2001

Member, Center for Biostatistics in AIDS Research Design Review Committee, Harvard School of Public Health, 1999-2001

Chair, Department of Biostatistics Committee on the Future of Public Health, Harvard School of Public Health, 2000-2001

Member, Department of Biostatistics Degree Program Committee, Harvard School of Public Health, 2000-2001

Member, Department of Biostatistics Teaching Effectiveness Committee, Harvard School of Public Health, 2000-2001

Member, Department of Biostatistics Webpage Committee, Harvard School of Public Health, 2000-2001

Member, Department of Biostatistics Core Curriculum Committee, University of Washington School of Public Health, 2002-2004

Member, Department of Biostatistics Faculty Development Committee, University of Washington School of Public Health, 2002-2006

Member, Department of Bio/Statistics PhD Theory Exam Committee, University of Washington School of Public Health, 2004-2005

Member, Department of Bio/Statistics PhD Applied Exam Committee, University of Washington School of Public Health, 2006-2007

13. Professionally-Related Community Service

14. [Other Pertinent Information As Needed]

15. Teaching History

a) Formal Courses

Statistical Methods in Biology (DBB 207cd), Division of Biological Sciences, Harvard School of Public Health, 5 credits, 2000

 Regression and ANOVA in Experimental Research (Bio 211), Harvard School of Public Health, 5 credits, 2001

Seminar in Biostatistics (Biostat 580), Department of Biostatistics, University of Washington, 1 credit, Winter 2002

Medical Biometry III (Biostat 513), Department of Biostatistics, University of Washington, 4 credits, Spring 2003

 Evaluating Vaccine Efficacy (Biostat 578A), Department of Biostatistics, University of Washington, 4 credits, Winter 2006

b) Other Teaching

Miscellaneous guest lecturer for courses at the Harvard School of Public Health, 1997-2000
Biostatistics Consultation (Bio 312ab and Bio 312cd), Department of Biostatistics, Harvard School of Public Health, 1998-1999
(director of the Biostatistics Department's student consultation laboratory for two semesters)

School of Modern Statistical Methods in Medical Research, International Centre for Theoretical Physics, Trieste, Italy, 1999
(course developer and lecturer. Presented 4 lectures on the design and analysis of HIV-1 vaccine and antiretroviral clinical trials)

Statistics, Data Management, and Monitoring of Clinical Trials (one-week short course, Part I), Institute of Population Scientific Research, Mahidol University, Bangkok, Thailand, 1999
(co-course developer and lecturer. The World AIDS Foundation-funded course emphasized clinical trials for HIV-1 vaccines and treatments)

Statistics, Data Management, and Monitoring of Clinical Trials (one-week short course, Part II), Department of Biostatistics, Mahidol University, Bangkok, Thailand, 2000
(co-course developer and lecturer. The World AIDS Foundation-funded course emphasized clinical trials for HIV-1 vaccines and treatments)

Miscellaneous guest lecturer for courses at the University of Washington School of Public Health (Biostat 511, EPI 590B), 2004-2007

c) Independent Study

--------------, Department of Biostatistics, Harvard School of Public
(1 semester), 2000-2001
--------------, Department of Biostatistics, University of Washington
(2 quarters), 2002
--------------, Department of Biostatistics, University of Washington (1 quarter), 2006
--------------, Department of Biostatistics, University of Washington, 2005-present
--------------, Department of Biostatistics, University of Washington, 2005-present

16. Advising and Formal Mentoring

--------------, Department of Biostatistics, University of Washington, 2002-2005
--------------, Department of Biostatistics, University of Washington, 2006-present
--------------, Department of Biostatistics, University of Washington, 2006-present

b) Masters Theses, chair

------------, Department of Biostatistics, University of Washington, 2005-2006
------------, Department of Biostatistics, University of Washington, 2005-present

c) Mentored Scientists and Postdoctoral Fellows

--------, Fred Hutchinson Cancer Research Center, 2005-2007

Member, Doctoral Committee

--------------, Department of Biostatistics, Harvard School of Public Health, 1998-1999
--------------, Department of Biostatistics, Harvard School of Public Health, 1999-2001
--------------, Harvard School of Dental Medicine, Harvard School of Public Health, 2001
--------------, Department of Biostatistics, University of Washington, 2002
--------------, Department of Biostatistics, University of Washington, 2002
--------------, Department of Biostatistics, University of Washington, 2004
--------------, Department of Statistics, University of Washington, 2004-2006
--------------, Department of Biostatistics, University of Washington, 2006-2007
--------------, Department of Biostatistics, University of Washington, 2006-present

Member, Masters Committee

---------------, Department of Pharmacy, Northeastern University, 1998-1999
---------------, Department of Epidemiology, University of Washington, 2003-2005

e) Other Mentoring (Undergraduate Research, Medical School ISMS Projects, etc.)

Research Assistant Supervision

-----------, Department of Biostatistics, University of Washington, 2003-2004
-----------, Department of Biostatistics, University of Washington, 2004-2006
-----------, Department of Biostatistics, University of Washington, 2004-2006
-----------, Department of Biostatistics, University of Washington, 2006-present
-----------, Department of Biostatistics, Univeristy of Washington, 2007
-----------, Department of Biostatistics, University of Washington, 2007-present

f) Academic Advising

Not applicable

• Statistical methods research with University of Washington Biostatistics students and postdoctoral fellows in the areas: Evaluation of candidate surrogate endpoints; High-dimensional variable selection methods; Causal inference methods for addressing post-randomization selection bias; Stepped wedge cluster-randomized prevention trial designs.
• Senior statistician for a Phase IIb HIV vaccine efficacy trial (PAVE 100) in Southern Africa, Eastern Africa, and the Americas, being planned for possible commencement in 2008
• Statistical methods and data analysis work for the Center for HIV/AIDS Vaccine Immunology (CHAVI)
• Leading a collaborative endeavor with Bette Korber's HIV sequence analysis group at the Los Alamos National Laboratory. Currently analyzing thousands of HIV sequences to explore potential mechanisms of HIV transmission and evolution, to discover clues that may inform HIV vaccine design
• As a faculty member of SCHARP’s Vaccine Immunology Statistical Center (VISC) for the Gates Foundation’s Collaboration for AIDS Vaccine Discovery (CAVD), will conduct statistical consulting with immunology labs that are part of the CAVD
• Collaborating on statistical methods development for analyzing neutralization data.
• Collaborating on the design and statistical analysis of repeated low-dose non-human primate vaccine challenge experiments. A focus of new statistical methods research, given promising opportunities to conduct large challenge trials.
• As PI of SCHARP’s subcontract with the Seattle Biomedical Research Institute (SBRI) malaria clinical research program, statistical collaboration for observational studies of placental malaria in mothers and their infants in Tanzania.
• Currently helping to build a core of expertise in high dimensional data methodology and analysis tools at SCHARP, to address the many scientific questions and data sets involving high dimensional data for HVTN, CHAVI, and VISC.
• Overseeing the development of 1 or 2 R packages, to make recently published statistical methods publicly available for practical implementation.
• Collaboration with Julie McElrath’s immunology lab on statistical analysis of flow-cytometry-derived memory marker data, for discovery of immunological biomarkers predictive of HIV disease progression.
• Nominated for appointment as the biostatistician on the FDA’s Vaccines and Related Biological Products Advisory Committee

PHS 398/2590 Other Support

ACTIVE

PHS Member Faculty Support Ongoing Institutional Support 0.6 Calendar

1 U01 AI068635-01 (S Self)     6/29/2006 - 5/31/2013 6 Calendar
NIH/NIAID     $733,333
Leadership for HIV/AIDS Clincal Trials Networks: HIV Vaccine Trials Network
This application to be the Statistical and Data Management Center (SDMC) describes how the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) will (1) provide statistical leadership for the design, conduct, analysis and publication of Network clinical trials/studies; (2) provide central data management capability that includes randomization, data set and case report form design, central storage, security, processing and retrieval of study results; (3) provide data management and protocol training throughout the Network; (4) provide data-focused clinical trials implementation, and operation; and (5) contribute to cross-Network efforts in developing common data elements.

1 R01 AI054165 (Gilbert)     4/1/2003-3/31/2010      2.4 Calendar
NIH/NIAID     $175,000
Statistical Methods in HIV Vaccine Efficacy Trials
The objective of this research is to conduct statistical research on four problems that arise in the design and analysis of preventative HIV vaccine efficacy trials. 1. Development of statistical methods for assessing the impact of HIV genotypic and phenotypic variation on the efficacy of HIV vaccines (“sieve analysis”). 2. Development of statistical methods for assessing the effect of vaccination on biomarker outcomes measured after HIV infection. 3. Development of a general semiparametric longitudinal regression model of a biomarker process that flexibly accommodates time-varying covariate effects and facilitates model selection. 4. Development of procedures to assess the effect of vaccination over time on the risk of HIV infection and on the risk of post-infection outcomes.

1 U01 AI067854 (Haynes)     7/1/2007-6/30/2010     1.2 Calendar
NIH/NIAID (Subaward from Duke University)     $1,059,612
Center for HIV/AIDS Vaccine Immunology (CHAVI)
The CHAVI SDMC will provide statistical consulting and study data management services to CHAVI. This will include support of the seven planned studies plus any additional studies.

38744 (Self)     7/1/2006-7/1/2011     1.2 Calendar
Bill & Melinda Gates Foundation     $---------
Vaccine Immunology Statistical Center (VISC)
The VISC for the Center for AIDS Vaccine Discovery will provide 1) statistical and study design support for pre-clinical vaccine performance trials, 2) centralized data management services for the standardized evaluation of vaccine candidates, 3) development of new statistical methods for cross-species correlates-of-protection analysis.

Duffy     12/1/2007-11/30/2008     0.6 Calendar
NIH/NIAID (Subaward from Seattle Biomedical Research Institute)
Malaria Antigen Discovery Program
Statistical collaboration for observational studies of malaria infection and disease in infants and children in Tanzania.