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US Food and Drug Administration
3 days ago
FDA Fellowship in Applied Regulatory Science in Bioinformatics and Omics Biomarker Discovery U.S. Food and Drug Administration (FDA) in United States
Degree Level
Postdoc
Field of study
Computer Science
Funding
Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to FDA recommendation and availability of funds.
Deadline
Dec 11, 2026
Country
United States
University
US Food and Drug Administration
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About this position
This FDA fellowship is based in the Division of Applied Regulatory Science within the Office of Clinical Pharmacology, Office of Translational Sciences, at the Center for Drug Evaluation and Research in Silver Spring, Maryland. The project sits at the intersection of bioinformatics, biostatistics, and regulatory science, with a focus on using large-scale omics data to advance biomarker discovery for drug development and review.
The fellow will work on statistical analysis of omics datasets generated from biospecimens drawn from clinical trials or well-characterized cohorts. The research aims to identify biomarkers related to disease expression, disease severity, progression, and therapeutic response, and to evaluate molecular signatures that may support regulatory decision-making. Methods mentioned include differential expression analysis, multivariate and systems-level analysis, pathway and network analysis, correlation analysis, data visualization, and statistical modeling.
The opportunity is embedded in a regulatory research environment that seeks to move new science into the review process and bridge scientific innovation with medical product evaluation. The work is intended to support the development of qualified regulatory tools and standardized endpoints, while contributing to the assessment of innovative omics technologies. The fellowship also includes literature review and manuscript preparation as part of dissemination of the research.
The mentor for this opportunity is Paula Hyland at the FDA.
Funding details
Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to FDA recommendation and availability of funds.
What's required
The candidate should be currently pursuing or have received a doctoral degree in a relevant field such as molecular biology, cell biology, genetics or genomics, biomedical sciences, pharmaceutical sciences, bioinformatics, biostatistics, or a closely related discipline. Preferred skills include statistical analysis methods such as differential expression analysis, multivariate statistics, and correction for multiple comparisons (for example Bonferroni, Benjamini-Hochberg, and FDR); experience with one or more omics data types including proteomics, genomics, transcriptomics, metabolomics, or epigenomics; working knowledge of R and Python and data visualization tools; familiarity with pathway analysis methods; experience with quality control procedures for high-throughput biological data; and knowledge of data mining approaches for biomarker discovery with ability to interpret findings biologically. Strong teamwork, organizational, communication, time-management, multitasking, prioritization, and independent/collaborative working skills are also preferred.
How to apply
Scroll to the bottom of the opportunity and click APPLY. Submit 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-2026-0186.
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Make your next move.
Prepare your application
Review drafts and confirm requirements with the university.