FDA Postdoctoral Fellowship: Infrastructure and Methods Development for Sustainable Real-World Evidence Monitoring

Research Project

This fellowship will offer you the opportunity to participate in the following specific project goals:

• Help the RWE Analytics Team in developing and validating optimized workflows and analytical methods to improve efficiency, consistency, and scalability of RWE submission monitoring and public reporting.
• Contribute to creation of comprehensive technical documentation and standard operating procedures to help program continuity and knowledge transfer.
• Help with longitudinal analysis of RWE monitoring data (FY 2023-2027) to identify trends and inform future regulatory science initiatives.

Learning Objectives

Upon completion of this fellowship, you will be able to:

• Apply regulatory science principles and FDA evaluation frameworks to assess the quality, reliability, and regulatory utility of real-world evidence submissions in support of drug approval and post marketing requirements.
• Design and implement health informatics workflows and data management systems to support systematic monitoring, capture, and analysis of regulatory submissions containing real-world data from diverse sources.
• Evaluate methodological approaches used in real-world evidence studies across different regulatory contexts, including externally controlled trials, observational studies, and post marketing safety surveillance, and communicate findings to regulatory and scientific audiences.

Mentor

The mentor for this opportunity is Joel Weissfeld (joel.weissfeld@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

The anticipated appointment start date is 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation

The appointment is full time.

Participant Stipend

The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

Program Information

The qualified candidate should be currently pursuing or have received a doctoral degree in the one of the relevant fields.

• Discipline(s): Life Health and Medical Sciences (51)

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

and

I have read the FDA Ethics Requirements.

Additional Resources

The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!