About FDA

CDER - Office Of Biostatistics

The Office of Biostatistics is currently recruiting Mathematical Statisticians (GS-1529 – PhD level) and Statistical Analysts (GS-1530 – MS level) for available positions within all of its Biometrics divisions.

Introduction

Located in the Office of Translational Sciences within the Center for Drug Evaluation and Research (CDER), the Office of Biostatistics (OB) is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based quantitative decision making throughout the drug development life cycle. We provide statistical leadership, expertise and advice to foster the expeditious development of safe and effective drugs and therapeutic biologics for the American people.

Through the application of state of the art regulatory science and statistical principles we:

  • Provide leadership, direction, policy development, and coordination to CDER on statistical, mathematical, and computational aspects of review, evaluation, and research
  • Develop statistical and mathematical methods to enhance the drug review and development processes through research on clinical trial methodology as well as drug safety monitoring, risk assessment and product quality assessment
  • Evaluate and utilize analytic statistical and mathematical simulation software to enhance the drug development process

With a staff of approximately 200 and a workload of statistical reviews numbering in the thousands each year, we also conduct methodological research into new and innovative methods of clinical trial design and analysis. We develop advances in precision medicine/ targeted therapies and the use of real-world evidence to supplement our knowledge base from clinical trials. We are utilizing innovative Bayesian methods for monitoring accruing evidence of safety information about marketed drugs. We are exploring more innovative thinking in the way we evaluate evidence provided by clinical trials such as Bayesian and complex adaptive designs.

Mission

Provide CDER and other internal and external stakeholders with statistical leadership, expertise, and advice to foster the expeditious development of safe and effective drugs and therapeutic biologics for the American people. Protect the public health by applying statistical approaches for monitoring the effectiveness and safety of marketed drugs and therapeutic biologic products.

Vision

The Office of Biostatistics is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle.

Office of Biostatistics Role and Responsibilities

The Office of Biostatistics provides independent and collaborative evaluations and reviews to all programs and disciplines of CDER in support of CDER's scientific and regulatory review process. OB statisticians are assigned to one of eight Divisions of Biometrics within the Office of Biostatistics. They work with the 16 new drug and biologic review divisions as well as the nonprescription product division in the Office of New Drugs (OND), epidemiologists in the Office of Surveillance and Epidemiology, scientists in the Office of Pharmaceutical Quality, and review staff in the Office of Generic Drugs, serving as members of multi-disciplinary review teams. The first five divisions of biometrics (DB I-V) are aligned with offices of drug evaluation in OND and are responsible for providing statistical reviews of new and supplemental drug applications (NDAs and sNDAs) as well as investigational new drug applications (INDs) and therapeutic biologics licensing applications (BLAs). The sixth division (DB VI) consists of special project teams that support nonclinical and clinical reviews and research in special topic areas, including pharmacology/toxicology, manufacturing quality issues, drug abuse potential/deterrence, analytical similarity, and cardiovascular safety concerns. DB VII provides statistical reviews to investigate specific safety issues that arise during pre-market drug development as well as post-market surveillance. DB VIII supports the Office of Generic Drugs (OGD) and is responsible for statistical reviews of generic drug applications (ANDAs) and supports various research projects identified by the Office of Research and Standards in OGD.

OB statisticians utilize and evaluate analytic statistical and mathematical simulation software to enhance their statistical review and research work. OB statisticians provide leadership and guidance to industry on statistical, computational and mathematical aspects of CDER's programs. We also provide training and mentoring to CDER staff in biostatistics and related areas. Our responsibilities extend to the discussion of statistical and regulatory issues at FDA Advisory Committees, and we make presentations on CDER statistical policy and regulatory research at scientific and professional meetings. Furthermore, we provide support to CDER on information technology issues related to the statistical review process, including the processing and analysis of data in electronic submissions.

Office of Biostatistics Organization

  • Lisa LaVange, PhD, Director
  • Aloka Chakravarty, PhD, Deputy Director
  • Vacant, Associate Director (Statistical Science and Policy)
  • Sue-Jane Wang, PhD, Associate Director (Pharmacogenomics)
  • Vacant, Associate Director (Biosimilar Review)

Division of Biometrics I

  • James Hung, PhD, Director

Supports Office of Drug Evaluation I (ODE I)

Division of Cardiovascular and Renal Products

Division of Neurology Products

Division of Psychiatric Products

and Office of Drug Evaluation IV

Division of Medical Imaging Products

Division of Biometrics II

  • Thomas Permutt, PhD, Director

Supports Office of Drug Evaluation II(ODE II)

Division of Anesthesia, Analgesia, and Addiction Products

Division of Metabolism and Endocrinology Products

Division of Pulmonary, Allergy and Rheumatology Products

Division of Biometrics III

  • Stephen E. Wilson, Dr.PH., Director

Supports Office of Drug Evaluation III (ODE III)

Division of Gastroenterology and Inborn Errors Products

Division of Dermatology and Dental Products

Division of Reproductive and Urologic Products

Division of Biometrics IV

  • Dionne Price, Ph.D., Director

Supports Office of Antimicrobial Products (OAP)

Division of Anti-Infective Products

Division of Transplant and Ophthalmology Products

Division of Antiviral Products

Division of Biometrics V

  • Rajeshwari Sridhara, Ph.D., Director

Supports Office of Hematology and Oncology Products (OHOP)

Division of Oncology Products (DOP1)

Division of Oncology Products (DOP2)

Division of Hematology Products

Division of Biometrics VI

  • Yi Tsong, Ph.D., Director

Supports reviews related to pharmacology/toxicology, new drug bioequivalence, thorough QT studies within the Office of New Drugs; drug abuse and abuse deterrence studies within the Controlled Substance Staff, in vivo bioequivalence within the Office of Testing and Research of the Office of Generic Drugs, and analytical biosimilarity within the Office of Biotechnology Products

Division of Biometrics VII

  • Mark Levenson, Ph.D., Director

Supports Office of Surveillance and Epidemiology (OSE) and OND’s Division of Nonprescription Drug Products in Office of Drug Evaluation IV
Provides quantitative safety evaluations and expertise to support CDER regulatory decisions throughout the lifecycle of regulated drug and biological products. In particular, this division has unique expertise in statistical and epidemiological methods relevant to safety evaluation, including design and analysis of safety clinical trials, design and analysis of observational studies, meta-analysis, signal detection, survey methodology, time series analysis, and graphical and computational tools. Also, provides statistical support for the Division of Nonprescription Drugs for human factors and use studies.

Division of Biometrics VIII

  • Stella Grosser, Ph.D., Director

DB VIII supports the Office of Generic Drugs (OGD) and is responsible for statistical reviews of generic drug applications (ANDAs) and supports various research projects identified by the Office of Research and Standards in OGD.

Statistical Policy Council
MAPP 6610.1: Statistical Policy Council

The Statistical Policy Council (SPC) provides statisticians working within CDER with a mechanism for identifying and resolving important statistical policy issues and establishing consistent statistical policy and procedures across the various biostatistical components within CDER. The SPC also serves as a venue for dealing with statistical review issues.

During the review of INDs, NDAs, and ANDAs, statistical policy questions arise for which there may be no clear policy or precedent. Such statistical issues can relate to study design, statistical aspects of data handling, and the analyses of data. Occasionally, CDER may be challenged on its perceived statistical standard or on the manner with which statistical decisions are reached. Statistical policy issues have been addressed by establishing ad hoc working groups that are charged with the responsibility of sorting out the policy issues in question.

Statistical Rounds
On a monthly basis, Statistical Reviewers from Biometrics Divisions present particularly challenging or noteworthy cases that are discussed with the Office of Biostatistics senior statistical counsel. Reviewers identify key information, issues, and questions in preparation for response to sponsor meetings, presentation before Advisory Committee, or final decision on analysis and evaluation of NDA submissions.

Office of Biostatistics Interactions with CDER Advisory Committees
Advisory Committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies. The Committees meet publically to discuss and weigh in on matters for which FDA seeks advice. CDER has over 18 committees organized by therapeutic area and cross-therapeutic areas such drug safety. The Committee memberships consist of a range of subject matter experts, including clinicians, pharmacists, patient representatives, and statisticians. OB statisticians routinely contribute to background packages and present at Advisory Committee meetings.

Expert statisticians interested in learning more about the role of statistician members and consultants to CDER Advisory Committees should contact the Office of Biostatistics Director, Dr. Lisa LaVange, Lisa.LaVange@fda.hhs.gov.

Office of Biostatistics Recruitment Program
The Office of Biostatistics recruits statisticians through a continuous search for qualified master’s and doctoral degree candidates who are interested in the areas of statistical programming (for GS-1530 positions) and statistical methods in clinical trial conduct and evaluation, risk assessment, and pharmacovigilance (for GS-1529 positions.)

Working as a statistician reviewer in the Office of Biostatistics offers an exceptional way of developing experience in regulatory statistical issues, diverse methodologies, clinical trial designs, and drug indications. Reviewers collaborate with highly trained statisticians and other regulatory scientists. They can also engage in scientific and regulatory research and participate in programs of professional societies and associations. Their efforts are supported through research grants and publishing opportunities. Most importantly, Office of Biostatistics regulatory statisticians serve to protect the American public in assuring that safe and effective drugs are made available to the American public. Information on employment with the Food and Drug Administration is available on both the FDA and CDER web sites:

Food and Drug Administration

FDA Center for Drug Evaluation and Research

Questions of interest can be sent directly to the Office of Biostatistics recruitment committee at CDER-OTS-OB-Recruitment@fda.hhs.gov.

FDA Statistical Research
OB statisticians and analysts conduct independent research on statistical methodologies pertinent to CDER’s scientific mission and regulatory review process, and collaborate with other offices and disciplines on their regulatory research programs. Our research spans such broad areas as clinical trials, Bayesian statistics, signal detection, causal inference, meta-analysis, bioequivalence, benefit-risk assessment, and product quality assessment and control.

Publications from Office of Biostatistics Staff

FDA Statistical Association (FDASA)
The statistical staff in the Office of Biostatistics at CDER participate in activities of the FDA Statistical Association (FDASA). This association of statistical scientists from 7 FDA centers was formed to serve as a collective voice in promoting the advancement of statistical sciences within the regulatory environment of the FDA. The Association addresses issues specific to the concerns of all FDA statisticians and fosters FDA-wide consistency and harmonization on crucial regulatory statistical issues.

The Association follows this mission by conducting inter-center seminars on common regulatory statistical issues and conducting workshops and conferences on both common and special issues. FDASA also promotes continuing education activities and programs for FDA Regulatory Statistical Scientists and encourages increased communications among FDA statistical scientists. Additionally, the Association supports statistically-focused educational programs for other FDA scientists.

How to Contact Us
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Page Last Updated: 08/17/2017
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