Center for Drug Evaluation and Research (CDER) statisticians provide the center with statistical expertise, leadership, and advice. They perform research in statistics as it applies to clinical trials and the drug evaluation process. Statistical staff members promote the advancement of statistical sciences throughout the FDA and foster agency-wide consistency and harmonization on crucial regulatory statistical issues.
The biostatistics program at CDER is recognized as a center of excellence for the development, research, application, and communication of statistical methodology for drug regulation and development. Our statisticians develop statistical and mathematical methods to enhance drug review and development through research on a wide range of topics including – but not limited to - clinical trial methodology, modeling in pharmacokinetics, bioequivalence and bioavailability testing, drug safety monitoring, and product quality assessment.
For more information about biostatistics at CDER please visit Office of Biostatistics: Statistical Research.