Publisher
source

US Food and Drug Administration

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

Degree Level

Postdoc

Field of study

Computer Science

Funding

Full-time ORISE postdoctoral fellowships with one-year appointments that 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; no employment-related benefits are provided.

Deadline

May 1, 2027

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Country

United States

University

US Food and Drug Administration

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Keywords

Computer Science
Data Science
Epidemiology
Information Technology
Biology
Mathematics
Systematic Review
Medical Science
Salud Pública
Regulatory Science
Evidence Synthesis
Pharmacoepidemiology
Statistics

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About this position

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.

Funding details

Full-time ORISE postdoctoral fellowships with one-year appointments that 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; no employment-related benefits are provided.

What's required

Applicants should have received or be currently pursuing a doctoral degree (PhD or equivalent) in epidemiology, data science, mathematics, or statistics; a clinical doctorate such as PharmD or MD with relevant experience may also be considered. For one opportunity, the degree must have been received within the past five years or be anticipated by 2026-08-31. Preferred experience includes epidemiological study design, pharmacoepidemiology, drug safety/effectiveness/comparative effectiveness research, real-world data sources such as claims, electronic health records, or registry data, systematic/scoping reviews or evidence synthesis, and strong scientific writing and communication skills. Citizenship eligibility varies by opportunity: one is open to U.S. citizens, LPRs, and foreign nationals; the other is limited to U.S. citizens and LPRs.

How to apply

Apply through the Zintellect/ORISE opportunity page by scrolling to the bottom and clicking APPLY. Submit the application, transcripts, current resume/CV, and one educational or professional recommendation. For questions about the application process, email [email protected] and include the reference code.

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