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US Food and Drug Administration

Just Landed

FDA Rescue Therapy in Real-World Evidence (RWE) Studies U.S. Food and Drug Administration (FDA) in United States

Degree Level

Postdoc

Field of study

Biostatistics

Funding

Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to recommendation and availability of funds.

Deadline

Dec 18, 2026

Country flag

Country

United States

University

US Food and Drug Administration

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Keywords

Biostatistics
Mathematics
Randomized Controlled Trial
Medical Science
Causal Inference
Salud Pública
Statistics

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About this position

This research opportunity is based within the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland, with the possibility of limited hybrid participation. The project sits in a regulatory and methodological environment focused on evaluating safe and effective drugs and improving how treatment effects are defined and compared in clinical research.

The work centers on rescue therapy and other treatment changes in both randomized controlled trials and real-world evidence studies. The selected participant will help evaluate and compare estimand strategies for handling treatment discontinuation, switching, and additional or alternative therapy use across a range of clinical scenarios. The study emphasizes simulation-based assessment of realistic switching mechanisms and confounding structures, along with comparison of commonly used causal and statistical approaches.

Under mentor guidance, the participant will gain experience with the estimand framework described in ICH E9(R1), and apply methods such as inverse probability of censoring weighting, G-estimation, and related approaches. The project is designed to build practical skills in designing simulation studies, implementing statistical programming workflows, and assessing methods in terms of bias, precision, robustness, and trade-offs across different treatment-change scenarios.

Mentorship is provided by Shanti Gomatam and Yueqin Zhao within FDA CDER.

Funding details

Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to recommendation and availability of funds.

What's required

The qualified candidate should be currently pursuing or have received a doctoral degree in statistics, biostatistics, mathematics, or a related field. Preferred skills include a strong foundation in statistics, good programming skills preferably in R, and courses or experience in causal inference and/or observational data. Applicants must be U.S. citizens or Lawful Permanent Residents, and proof of health insurance is required. A successful background investigation is required for onboarding at FDA; the background investigation can only be completed for individuals who have resided in the U.S. for a total of three of the past five years.

How to apply

Apply through the Zintellect opportunity page by clicking APPLY at the bottom of the posting. Include an application, transcripts, a current resume/CV, and one educational or professional recommendation. If you have questions, email [email protected] and include the reference code FDA-CDER-2026-0189.

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