Meet ApplyKite Twin, the application assistant that learns with you
Meet your Twin, it learns with you
Your Twin learns with you
Launch week codes:30% off annual Pro20% off monthly Pro
Ends in00h00m00s
Ends in00h00m00s
US Food and Drug Administration
Just Landed
Posted Yesterday
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
United States
University
US Food and Drug Administration
Apply for this position
Keywords
Suggested positions
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.
Make your next move.
Prepare your application
Review drafts and confirm requirements with the university.
Make your next move.
Prepare your application
Review drafts and confirm requirements with the university.