Statistician Careers at CDER
Work for the FDA's Center for Drug Evaluation and Research (CDER)
What do Statisticians do at CDER?
The duties of a Statistician at CDER differ by office. Opportunities may include:
- Collecting and analyzing statistical data from clinical studies using specialized statistical software and general programming languages. Analyzing mathematical models, sample surveys, and statistical measurements and their application to regulatory policy and procedures.
- Evaluating proposals for the design, conduct, and analysis of regulated clinical studies. Suggesting and verifying methods, analyses in pilot studies, clinical trials, laboratory studies, and other research projects and providing guidance to ensure validity of inferences obtained from these studies.
- Performing statistical reviews of investigational applications and marketing applications such as Biologics License Applications (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and supplements for adequacy of design, conduct, and analysis of regulated clinical studies.
- Analyzing epidemiological/observational data from health records, registries, natural history studies and contract databases to answer review questions concerning the life cycle safety, efficacy, and use of regulated drugs and biologics.
- Evaluating scientific, statistical, and regulatory developments. Analyzing complex mathematical models, sample surveys, and statistical measurements and their application to regulatory policy and procedures. Preparing statistics regulatory reports and documentation.
- Designing and producing code for methods development, developing software using the appropriate statistical programming packages, and guiding the purchase and installation of new software.
- Working in collaborative, multidisciplinary groups of FDA, sponsor, and academic statisticians, scientists, engineers, and physicians to translate medical questions and concerns into appropriate statistical analyses.
- Attending presentations and conferences to retain and enhance professional competency and participating in activities of relevant professional societies. Giving briefings to senior statisticians, professional colleagues, FDA advisory panels, and upper management.
- Maintaining knowledge of the professional literature in the statistical field. Determining the applicability of previous research to the current problem, evaluating the utility of existing statistical methods, and defining modifications, when necessary, to statistical techniques.
Related positions include:
- Clinical Analyst
- Computer Scientist
- Data Scientist
- Mathematical Statistician
- Operations Research Analyst
How can I find a Statistician position at CDER?
Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.
- Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 1530 - Statistics.
- Visit We Are Hiring | FDA to find a current listing of opportunities utilizing the FDA 21st Century Cures Act Hiring Authority.
Where can I learn more about careers at the FDA?
For general information on working at the FDA and additional employment opportunities, visit: Jobs and Training at FDA.