FDA Seeks Bioinformatics Fellow for Regulatory Science in Drug Evaluation
The U.S. Food and Drug Administration (FDA), specifically its Center for Drug Evaluation and Research (CDER), is offering a research fellowship in Bioinformatics and Omics Biomarker Discovery. This opportunity is within the Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Division of Applied Regulatory Science (DARS) in Silver Spring, Maryland. The fellowship aims to integrate new scientific advancements into the regulatory review process, focusing on biomarker discovery using large-scale proteomics data. The selected fellow will be involved in the statistical analysis of omics data to identify clinically meaningful biomarkers for disease progression, treatment efficacy, and patient stratification in clinical trials. This includes quality control, statistical modeling, multivariate analysis, pathway analysis, data visualization, and manuscript preparation. The goal is to develop qualified regulatory tools and support informed regulatory decision-making for drug development.