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US Food and Drug Administration

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FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease U.S. Food and Drug Administration (FDA) in United States

Degree Level

Master's

Field of study

Computer Science

Funding

Monthly stipend commensurate with educational level and experience; appointment initially for one year and renewable contingent on funding.

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Country

United States

University

US Food and Drug Administration

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Keywords

Computer Science
Mathematics
Medical Science
Salud Pública
Regulatory Science
Statistics
Trial Design
Rare Disease
Myelofibrosis

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About this position

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 myelofibrosis, with the intent to extend the framework to other rare non-malignant hematologic diseases such as PNH, SCD, anemia of CKD, WAHI, ITP, hemophilia, and others.

Research activities include surveying and synthesizing endpoint strategies such as co-primary, composite, Hochberg, and win-ratio approaches; comparing statistical analyses from recent submissions and the literature; and evaluating clinical interpretability, multiplicity control, estimands, and alignment with regulatory expectations.

The fellow will also assess operating characteristics under realistic scenarios, including endpoint correlation, effect assumptions, and alpha requirements, and will compare power and other metrics to understand the strengths and limitations of competing strategies. The project further explores regulatory flexibility for rare diseases, including potential use of real-world evidence and Bayesian borrowing to address sample size and ethical concerns.

Work will be carried out in collaboration with the statistician at DB9 and the clinical team in the Division of non-malignant hematology to connect endpoints with disease biology and patient-meaningful benefit, and to develop annotated case studies that highlight trial operational characteristics.

The experience includes simulation-based assessment, regulatory science documentation, internal meetings, guidance from mentors, presentation opportunities, and the possibility of co-authoring a manuscript based on the project findings.

Funding details

Monthly stipend commensurate with educational level and experience; appointment initially for one year and renewable contingent on funding.

What's required

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in a relevant field. Applicants must provide an application, transcripts, a current resume/CV including academic history, employment history, relevant experiences, and publication list, and one educational or professional recommendation. All documents must be in English or include an official English translation. Citizenship requirements state the opportunity is open to U.S. citizens, lawful permanent residents, and foreign nationals; non-U.S. citizens must meet acceptable immigration status guidelines, and applicants must be able to satisfy the background investigation requirement, including having resided in the U.S. for a total of three of the past five years. Proof of health insurance is required.

How to apply

Go to the application link and scroll to the bottom of the opportunity page, then click APPLY. Prepare the application, transcripts, CV/resume, and one recommendation before submitting. If you have questions, email [email protected] and include the reference code.

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