FDA Statistical Evaluation of TD50 and Benchmark Dose Approaches for Carcinogenic Impurities Acceptable Intakes U.S. Food and Drug Administration (FDA) in United States

This FDA Fellowship at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) is focused on developing a practical framework for selecting primary endpoint strategies and building the corresponding statistical analysis plan for non-malignant hematologic diseases in confirmatory trials. The participant will work with statistical and clinical reviewers on a regulatory-science project that begins with historical NDA/BLA trials and selected ongoing IND trials in myelo...

U.S. Food and Drug Administration (Center for Devices and Radiological Health) is offering a research opportunity in Silver Spring, Maryland focused on assessment of Bayesian statistical methods applied in regulatory contexts . The project sits within FDA’s regulatory science environment and is tied to the agency’s mission to support safe, effective, and high-quality medical devices through science-based decision-making. The participant will work on a multi-part research effort centered on how B...

PhD opportunity in Epidemiology and Biostatistics at the University of Pennsylvania (Perelman School of Medicine), within the Epidemiology and Biostatistics Graduate Group (GGEB) and Biomedical Graduate Studies (BGS). This is a fully funded PhD position with a $49,000/year stipend , plus tuition, fees, health insurance, and a $1,000 relocation award . The program is designed to train rigorous, independent investigators who apply biostatistical and epidemiological methods to biomedical research q...

This research opportunity at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) focuses on the methodological evaluation of validation approaches for AI/ML-based predictive medical devices in regulatory settings. The project centers on structured landscape analysis of device submissions, including 510(k) , De Novo , and PMA SSEDs , to characterize predictive and prognostic claims, clinical study designs, performance metrics, validation strategies, and stati...

Two postdoctoral fellowship opportunities are available in the Office of Medical Policy, Real-World Evidence Analytics Team at the U.S. Food and Drug Administration (FDA) , within the Center for Drug Evaluation and Research (CDER). These ORISE-administered fellowships are designed for early-career researchers interested in regulatory science , epidemiology , data science , health informatics , and the use of real-world evidence (RWE) in drug regulation. The first project, Advancing Regulatory Sc...