Postdoctoral Fellowships in Real-World Evidence Analytics and Regulatory Science at the U.S. Food and Drug Administration U.S. Food and Drug Administration in United States

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 Science through Real-World Evidence: Synthesis, Gap Analysis, and Strategic Direction, focuses on systematically characterizing FDA’s RWE demonstration project portfolio, building an evidence map, identifying methodological themes and best practices, publishing findings, and conducting a gap analysis to inform future research and funding priorities.

The second project, Infrastructure and Methods Development for Sustainable Real-World Evidence Monitoring, focuses on developing and validating workflows and analytical methods for RWE submission monitoring and public reporting, creating technical documentation and SOPs, and analyzing longitudinal monitoring data to support regulatory science initiatives.

Both appointments are full time, initially for one year, and may be renewed depending on FDA recommendation and availability of funds. Participants receive a monthly stipend commensurate with educational level and experience. Health insurance is required. These are not employment positions and do not include employment-related benefits.

Eligibility differs slightly by project. One opportunity is open to U.S. citizens, lawful permanent residents, and foreign nationals; the other is limited to U.S. citizens and lawful permanent residents. Applicants should have a doctoral degree (PhD or equivalent) in epidemiology, data science, mathematics, or statistics, or a clinical doctorate such as PharmD or MD with relevant experience. Preferred experience includes pharmacoepidemiology, drug safety/effectiveness research, real-world data sources such as claims, EHRs, or registry data, systematic reviews, and strong scientific writing.

Applications are submitted through Zintellect/ORISE. The listed deadline for one opportunity is 2027-05-01, and the other opportunity lists 2026-07-31. Interested candidates should review the specific opportunity page, prepare the required application materials, and contact [email protected] with the reference code for application questions.