FDA Fellowship - Office of Pharmaceutical Quality; OPQ Management Initiative - Data

Organization

U.S. Food and Drug Administration (FDA)

FDA-CDER-

Center for Drug Evaluation and Research (CDER), Silver Spring, Maryland.

Support the Office of Pharmaceutical Quality (OPQ) Assignment Tool initiative by improving data validation and algorithm performance. 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. Outcomes will enhance assignment allocation and improve the efficiency and consistency of pharmaceutical quality assessments.

• Analyze assignment data to identify workload distribution patterns.
• Develop and refine algorithms for assignment allocation.
• Apply mathematical modeling, programming, and statistical software.
• Integrate data systems and work with pharmaceutical quality submission data.
• Document findings and support decision‑making within the OPQ.

Gain experience in data analysis, algorithm development, and use of statistical software and data warehouses. Develop an understanding of OPQ business processes, databases, and regulatory assessment of drug applications.

Nancy Tian (nancy.tian.gov)

• Start date:
  
  July 1, 2026 (flexible)
• Duration: one year, renewable based on funding and recommendation.
• Participation: full time.
• Stipend: monthly stipend commensurate with educational level and experience.
• Citizenship:
  United States citizen or lawful permanent resident only.

• Master’s degree (currently pursuing or obtained) in a relevant field.
• Relevant disciplines:
  Chemistry, Materials Sciences, Biological Chemistry, Bio‑organic Chemistry, Biophysical Chemistry, Environmental Chemistry, Inorganic Chemistry, Organic Chemistry, Physical Chemistry, Polymer Chemistry, Theoretical Chemistry, Chemical Engineering.
• Proficiency in analytical chemistry, data analysis, and programming.
• Strong communication and graphic design skills (optional).
• Experience in computer, information, and data sciences, earth and geosciences, engineering, environmental and marine sciences, life health and medical sciences, mathematics and statistics, physics, social and behavioral sciences.

• Completion of a successful background investigation by the Office of Personnel Management.
• Adherence to FDA Ethics Requirements for Non‑employee Scientists, including disclosure and divestiture of financial interests related to controlled or prohibited investment funds.
• Read and sign the FDA Education and Training Agreement within 30 days of start date, covering non‑employee status, IP obligations, and confidentiality.

Full‑time appointment, stipend, and access to FDA resources and training. Participants are not employees of FDA, DOE, or program administrators and do not receive employment‑related benefits.