Office of Biostatistics

The Office of Biostatistics (OB) is part of the Office of Translational Sciences (OTS) . OB is recognized for excellence in the application and communication of statistical science in drug regulation and development. To support the mission of the Center for Drug Evaluation and Research (CDER), we provide statistical leadership, expertise, and advice for the development and the evaluation of drugs to ensure safe and effective drugs are available to the American people. We play a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life cycle.

What We Do

Drug Safety and Effectiveness Review

We ensure the safety and effectiveness of new drugs, therapeutic biologics, generic drugs, over-the-counter products, and biosimilar products throughout their lifecycle—from pre-market development through post-market surveillance. Our work includes:

Review of proposed studies intended to provide regulatory evidence, including:
- Alignment of the study design with the clinical and regulatory questions
- Reliability and relevance of endpoints
- Appropriateness and prespecification of the analysis
- Prevention and treatment of missing data
- Evaluation of assumptions of statistical methods
Review of New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs), including:
- Review of protocols, correspondence, and study reports to evaluate adequacy of design and conduct
- Assessment of data quality and validation of applicants' analyses
- Examination of the robustness and consistency of study findings
- Interpretation and integration of the study findings
- Recommendation on drug labeling
- Evaluation of the need for post-marketing commitments and requirements

Leadership and Program Support

We provide leadership and statistical support for CDER and FDA programs, including:

Analysis Data Standards
Artificial Intelligence and Machine Learning (AI/ML)
Chemistry, manufacturing, and controls (CMC)
Complex Innovative Designs (CID)
Digital Health Technologies (DHT)
Drug abuse study and mitigation
Drug Development Tools (DDT), including the Biomarker Qualification Program (BQP), Clinical Outcome Assessment (COA) Qualification Program, Animal Model Qualification Program (AMQP), and Innovative Science and Technology Approaches for New Drugs (ISTAND) Program
Patient-Focused Drug Development (PFDD)
Pharmacology/Toxicology
Real-World Data (RWD)/Real-World Evidence (RWE)
Rare Diseases
Safety Surveillance

Policy Development and Scientific Advancement

We develop and disseminate statistical policy and guidance, and advance statistical science through research, publications, and training 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-focus, psychometrics, and product quality assessment and control.

Recent Statistical Guidance Documents

Publications

Office Organization

OB Immediate Office

Mark Levenson, Ph.D., Director
Vacant, Deputy Director
Gregory Levin, Ph.D., Associate Director for Statistical Science and Policy

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 OB with respect to data standards, AI/ML, DHT, data quality and data integrity, scientific computing, data visualization tools, standardization of statistical programming tools and processes.

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

Dalong Huang, Ph.D., Acting Director
Atiar Rahman, Ph.D., Deputy Director

Provides statistical review of and consultation for:

Pharmacology/Toxicology
CMC Evaluations
Drug Abuse Potential and Abuse Deterrence Studies
Analytical Biosimilarity Studies
QT/QTc Studies
Other Nonclinical Studies

Division of Biometrics VII

Mat Soukup, Ph.D., Director
Vacant, Deputy Director

Provides statistical review of and consultation for:

Design and Analysis of Drug Safety Throughout the Drug Life Cycle, 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 and Regulatory Evaluation of RWE
Development and Regulatory Evaluation of Nonprescription Drugs

Division of Biometrics VIII

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

Focuses on providing support for research and the regulatory evaluation of:

Generic Drug Products and New Drug Bioequivalence Studies

Division of Biometrics IX

Yuan-Li Shen, Ph.D., Director
Vacant, Deputy Director

Focuses on the development and regulatory evaluation of:

Hematology Products, Including Hematologic Cancer Therapies

Work with Us

OB Recruitment Program

OB 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, pharmacovigilance, psychometrics, and decision science (Statistical Reviewers).
Working as a regulatory statistician offers an exceptional way of gaining experience in:

Regulatory Statistical Issues
Varied Methodologies
Clinical Trial Design
Drug Indications

New regulatory statisticians receive mentoring by highly trained statisticians and collaborate with other regulatory scientists. 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 FDA is available on both the FDA and CDER web sites.

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