• 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

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.

• Publications

Immediate Office (OB-IO)

Sylva H. Collins, Ph.D., Director 
Aloka Chakravarty, Ph.D., Deputy Director 
Matilde Kam, Ph.D., Associate Director (Analytics and Informatics)

Division of Biometrics I

James Hung, Ph.D., Director
Sue Jan Wang, Ph.D., Acting Deputy Director

Focuses on the development and regulatory evaluation of:

• Anesthesia, Analgesia, and Addiction Products
• Neurology Products
• Psychiatric Products
• Medical Imaging Products

Division of Biometrics II

Mark Rothmann, Ph.D., Director
Yun Wang, Acting Deputy Director

Focuses on the development and regulatory evaluation of:

• Cardiovascular and Renal Products
• Metabolism and Endocrinology Products
• Pediatrics and Maternal Health Products

Division of Biometrics III

Laura Lee Johnson, Ph.D., Director
Gregory Levin, Ph.D., Deputy Director

Focuses on the development and regulatory evaluation of:

• Dermatology and Dental Products
• Gastroenterology Products
• Hepatology and Nutrition Products
• Pulmonary, Allergy, and Rheumatology Products
• Transplant Products

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
• Rare Disease Products
• Reproductive and Urologic Products
• Ophthalmology Products

Division of Biometrics V

Shenghui Tang, Ph.D. Acting Director 
Yuan Li Shen, Acting Deputy Director​

Focuses on the development and regulatory evaluation of:

• Oncology 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 
• 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 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 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 and new drug bioequivalence studies

Division of Biometrics IX

Thomas Gwise, Ph.D., Director
Vacant, Deputy Director

Focuses on the development and regulatory evaluation of:

• Hematology Products

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.

• Interacting with FDA on Complex Innovative Trial Designs for Drugs and Biological Products (September 2019)  
• Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes (April 2019)
• Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products (November 2018)  
• Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry

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 publicly 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. Sylva Collins.

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 [email protected].

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 through 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.