FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety
Research Project
Through an ORISE fellowship, you will engage in a regulatory science research initiative to create an integrated database from randomized and controlled clinical trials for drugs intended to treat diabetes, overweight, and lipid disorders, enhancing FDA's safety signal detection capabilities. You will collaborate with a multidisciplinary team to develop frameworks for standardizing and combining subject-level data from hundreds of clinical trials, including over 20 completed cardiovascular outcome trials.
You will investigate approaches to harmonize diverse clinical trial datasets, and analyze complex data across multiple studies. Through this, you contribute to developing analytical tools for rapid regulatory response and participate in meta-analyses of adverse events across drug classes to support both premarket and postmarket safety evaluation.
Learning Objectives
- Weekly mentored meetings and monthly steering committee sessions with Office leadership
- Hands-on experience with clinical trial data management
- Training in FDA regulatory processes
- Instruction in clinical safety review
- Advanced statistical methods for safety signal detection
- Machine learning applications in pharmacovigilance
- Evidence synthesis techniques
Mentor
The mentor for this opportunity is Justin Penzenstadler (Justin.Penzenstadler@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Citizenship Requirements
- This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.
Qualification Requirements
- Currently pursuing or have received a doctoral degree in the relevant fields
- U.S. citizen or have lived in the United States for at least 36 out of the past 60 months
- Have read the FDA Ethics Requirements
Contact Information
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.