What are the responsibilities and job description for the FDA Fellowship - Office of Pharmaceutical Quality (OPQ) Initiative - Data Analysis position at U.S. Food and Drug Administration (FDA)?
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at Silver Spring, Maryland.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.
Research Project: This project supports the Office of Pharmaceutical Quality (OPQ) Assignment Tool initiative by improving data validation and algorithm performance. You will analyze assignment data from December 2025 to the present to identify workload distribution patterns and refine the algorithm using mathematical modeling, programming, and integrated data systems. Project outcomes will enhance assignment allocation and improve the efficiency and consistency of pharmaceutical quality assessments.
Learning Objectives: You will gain experience in data analysis, algorithm development, and the use of statistical software and data warehouses, while using pharmaceutical quality submission data. You will also develop an understanding of OPQ business processes, databases, and the regulatory assessment of drug applications.
Mentor: The mentor for this opportunity is Nancy Tian (nancy.tian@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 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 and Lawful Permanent Residents (LPR) only.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.