About FDA

CDER - Office Of Biostatistics

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

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. To support CDER’s mission, we provide statistical leadership, expertise, and advice to ensure that safe and effective drugs are available to the American people.

What We Do

  • Ensure the safety and effectiveness of new drugs, therapeutic biologics, generic drugs, and biosimilar products through pre-market review of drug development programs. Key aspects of our statistical review are to:
    • Check for data accuracy, quality, and completeness
    • Determine the validity of sponsor’s analyses and interpretability of results
    • Assess the robustness of results to check impact of unverifiable assumptions
    • Evaluate results in light of evidentiary standards
    • Assess risk and benefit to support product approval
    • Present and discuss reviews at advisory committee meetings
  • Ensure the safety of marketed drugs through:
    • Development of statistical methods for post-market surveillance
    • Review of post-market safety studies
  • Provide leadership and statistical support for CDER and FDA programs such as 
    • Analysis Data Standards
    • Complex Innovative Designs
    • Patient Focused Drug Development
  • Develop and disseminate statistical policy and guidance
  • Advance statistical science through research, publications, and training

FDA Statistical Research

Our statisticians conduct independent research on statistical methodologies relevant to CDER’s scientific mission and regulatory review process. Our research spans such broad areas as clinical trial design, Bayesian statistics, signal detection, causal inference, meta-analysis, bioequivalence, benefit-risk assessment, and product quality assessment and control.

View some of our publications here.

Office Organization

Immediate Office (OB-IO)

Aloka Chakravarty, PhD, Acting Director
Aloka Chakravarty, PhD, Deputy Director
Thomas Permutt, Ph.D., Associate Director (Statistical Science and Policy)
Shein-Chung Chow, PhD, Associate Director (Biosimilar Review)
Sue-Jane Wang, PhD, Associate Director (Pharmacogenomics)


Division of Biometrics I

James Hung, Ph.D., Director
Vacant, Deputy Director

Focuses on the development and regulatory evaluation of:

  • Cardiovascular and Renal Products
  • Neurology Products
  • Psychiatric Products
  • Medical Imaging Products

Division of Biometrics V

Rajeshwari Sridhara, Ph.D., Director
Thomas Gwise, Ph.D., Deputy Director

Focuses on the development and regulatory evaluation of:

  • Oncology Products
  • Hematology Products

Division of Biometrics II

Mark Rothmann, Ph.D., Acting Director
Vacant, Deputy Director

Focuses on the development and
regulatory evaluation of:

  • Anesthesia, Analgesia and Addiction Products
  • Metabolism and Endocrinology Products
  • Pulmonary, Allergy, and Rheumatology Products

Division of Biometrics VI

Yi Tsong, Ph.D., Director
Atiar Rahman, Ph.D., Deputy Director

Provides statistical review of and consultation for:

  • Pharmacology/toxicology and new drug bioequivalence studies
  • Chemistry, manufacturing, and controls (CMC) evaluations
  • Drug abuse potential and abuse deterrence studies
  • Analytical biosimilarity studies
  • QT/QTc studies
  • Other non-clinical studies

Division of Biometrics III

Laura Lee Johnson, Ph.D., Acting
Director
Vacant, Deputy Director

Focuses on the development and Regulatory evaluation of:

  • Dermatology and Dental Products
  • Gastroenterology and Inborn Errors Products
  • Reproductive and Urologic Products

Division of Biometrics VII

Mark Levenson, Ph.D., Director
Mat Soukup, Ph.D., Deputy Director

Provides statistical review of and consultation for:

  • Design and analysis of safety studies throughout drug life-cycles, including large randomized studies, observational studies, and meta-analyses
  • Surveillance of the safety of marketed drugs through Risk Evaluation and Mitigation Strategies (REMS), spontaneous adverse event reporting, and other data sources
  • Development of the regulatory framework for the use of real-world evidence(RWE)
  • Development and regulatory evaluation of non-prescription drugs

Division of Biometrics IV

Dionne Price, Ph.D., Director
Daphne Lin, Ph.D., Deputy Director

Focuses on the development and regulatory evaluation of:

  • Anti-infective Products
  • Antiviral Products
  • Transplant Products
  • Ophthalmology Products

Division of Biometrics VIII

Stella Grosser, Ph.D., Director
Fairouz Makhlouf, Ph.D., Deputy Director

Focuses on providing support for
research and regulatory evaluation of:

  • Generic Drug Products

Statistical Policy Council

The role of the Statistical Policy Council (SPC) is to provide a senior level forum to establish statistical policy for CDER and oversee its application in both pre- and post-market review activities.  The council also oversees the development of statistical guidance documents.

During a review, statistical issues may arise for which there is no established policy or procedure. Such statistical issues can relate to study design, study conduct, data handling, data analysis, and interpretation of study results. While some variation in the application of statistical methods across disease areas is expected and desired, the clear and consistent application of sound statistical principles throughout CDER is essential.

SPC members include the Director and Deputy Director, Associate Directors, and Division Directors in the Office of Biostatistics. SPC meets monthly or as needed to consider statistical policy issues.

Additional information about the SPC may be found here.

Work with Us

Advisory Committee Membership

Advisory Committees provide FDA with independent opinions and recommendations 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. Committees are organized by both therapeutic areas and across therapeutic areas (e.g. drug safety).

Committee memberships consist of a range of subject matter experts, including clinicians, pharmacists, patient representatives, and statisticians.

Expert statisticians interested in learning more about the role of Members or Consultant to CDER Advisory Committees should contact the Office of Biostatistics Director, Dr. Lisa LaVange.

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 (Statistical Analyst) and statistical methods in clinical trial conduct and evaluation, risk assessment, and pharmacovigilance (Statistical Reviewers).

Working as a regulatory statistician offers an exceptional way of gaining experience in:

  • regulatory statistical issues
  • diverse methodologies
  • clinical trial design
  • drug indications

New regulatory statisticians are mentored by highly trained statisticians and collaborate with other regulatory scientists on an ongoing basis. They engage in scientific and regulatory research and participate in professional societies and associations. Research efforts may be supported through grants.

Most importantly, regulatory statisticians serve to protect the American public by ensuring that safe and effective drugs are available.

Information on employment with the Food and Drug Administration is available on both the FDA and CDER web sites.

Additional information may be obtained by emailing The Office of Biostatistics Recruitment Committee at CDER-OTS-OB-Recruitment@fda.hhs.gov.

 

Opportunities for Students and Recent Graduates

The Office of Biostatistics participates in the Oak Ridge Institute for Science and Education (ORISE) Research Participation Training Program. The goal of this program is to provide practical scientific training for scientists and physicians though the performance of scientific projects on-site at the FDA. All of the projects will be relevant to the mission of the FDA. Additional information may be obtained here.

Website Feedback

We ask you to take time to communicate with CDER about this web site. Please send any comments to CDER-OB-Correspondence@fda.hhs.gov

 

Page Last Updated: 07/26/2018
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