Office of Biostatistics

The Office of Biostatistics is currently recruiting Statisticians (MS and PhD 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, over the counter products, and biosimilar products through pre-market review of drug development programs. Key aspects of our statistical review are to:
- Evaluate the appropriateness of proposed trial designs and analysis plans
- 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
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 (PFDD)
- Real World Data (RWD)/ Real World Evidence (RWE)
- Rare Diseases
- Digital Health Technologies (DHT)
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, patient focused drug development, psychometrics, and product quality assessment and control.

Publications

Office Organization

Immediate Office (OB-IO)

Sylva H. Collins, Ph.D., Director
Vacant, Deputy Director
Gregory Levin, Ph.D., Associate Director (Statistical Science and Policy)

Division of Biometrics I

James Hung, Ph.D., Director
Sue Jane Wang, Ph.D., 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, Ph.D., Deputy Director

Focuses on the development and regulatory evaluation of:

Cardiology and Nephrology Products
General Endocrinology Products
Diabetes, Lipids and Obesity Products
Pediatrics and Maternal Health Products

Division of Biometrics III

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

Focuses on the development and regulatory evaluation of:

Dermatology and Dentistry Products
Gastroenterology Products
Hepatology and Nutrition Products
Pulmonology, Allergy, and Critical Care Products
Rheumatology and Transplant Medicine Products
Patient Experience Data

Division of Biometrics IV

Lei Nie, Ph.D., Director
Daphne Lin, Ph.D., Deputy Director

Focuses on the development and regulatory evaluation of:

Anti-infective Products
Antiviral Products
Rare Disease and Medical Genetics Products
Urology, Obstetrics, and Gynecology Products
Ophthalmology Products

Division of Biometrics V

Shenghui Tang, Ph.D., Director
Pallavi Mishra-Kalyani, Ph.D., Deputy Director

Focuses on the development and regulatory evaluation of:

Oncology Products for Solid Tumors

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

Yuan-Li Shen, Ph.D., Director
Lisa Rodriguez, Ph.D., Deputy Director

Focuses on the development and regulatory evaluation of:

Hematology Products, including hematologic cancer therapies

Division of Analytics and Informatics

Maria Matilde Kam, Ph.D., Director
Paul Schuette, Ph.D., Deputy Division Director

Provides leadership and support for the computational and programming needs and initiatives across Office of Biostatistics (OB) with respect to data standards, data quality and data integrity, scientific computing, data visualization tools, standardization of statistical programming tools and processes.

Recent Statistical Guidance Documents

Multiple Endpoints in Clinical Trials (October 2022)
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products (May 2023)
Interacting with FDA on Complex Innovative Trial Designs for Drugs and Biological Products (December 2020)
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry (December 2019)
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products (November 2018)

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 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 CDEROTSHires@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 through the performance of scientific projects at the FDA. All of the projects will be relevant to the mission of the FDA. Additional information may be obtained here.

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