FDA of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

Overview

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, 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.

The projects will focus on using quantitative analyses to support pediatric extrapolation in Ulcerative Colitis (UC) and Crohn's disease (CD), to identify appropriate selection criteria in Duchenne Muscular Dystrophy (DMD) patients, to fine‑tune exposure‑response analysis in oncology, to improve dose selection in oncology and inflammatory & immune diseases, and to support risk and safety evaluation, to identify endpoints for Type 1 Diabetes.

During the appointment, you will use the clinical trial data under NDA and BLA submissions and published literature to cooperate in model building, covariate selection, and quantitative tool development. The findings are expected to be applied to innovate clinical trial design and streamline clinical development program, contributing to precision medicine.

The project provides training opportunities to understand quantitative approaches that can be applied to support new drug development. During the appointment, you will learn basic skills in drug development, modeling and simulation skills for dose findings, endpoint selection, identification of confirmative evidence, and patient selection. You will also be able to participate in internal FDA scientific discussions, gain knowledge on drug development and learn quantitative skills on clinical trial data.

• Use clinical trial data under NDA and BLA submissions and published literature
• Cooperate in model building, covariate selection, and quantitative tool development
• Apply findings to innovate clinical trial design and streamline clinical development program

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

• Degree:
  Bachelor's, Master's, or Doctoral.
• Discipline(s):
  • Computer, Information, and Data Sciences
  • Artificial Intelligence (including Robotics, Computer Vision, Human Language Processing, and Machine Learning)
  • Computer Architecture and Grids
  • Computer Science – Languages and Systems
  • Computer Science – Theoretical Foundations
  • Computer Science – General
  • Computer Systems Analysis
  • Computer Systems Design (including Signal Processing)
  • Data Science
  • Databases, Information Retrieval, and Web Search
  • Graphics and Visualization
  • Human Computer Interaction
  • Information Science and Technology
  • Information Security and Assurance
  • Networks and Communications
  • Operating Systems and Middleware
  • Scientific Computing and Informatics
  • Software Engineering
  • Engineering
  • Life Health and Medical Sciences
  • Mathematics and Statistics
• Citizenship: U.S. citizen, lawful permanent resident, or foreign national meeting eligibility requirements.
• Monthly stipend commensurate with educational level and experience.
• Participation is full time, initial appointment length is two years with potential renewal.
• Start date flexible.

Monthly stipend commensurate with educational level and experience. The appointment is full time and initially two years long, with potential renewal contingent on funding.

For questions, email ORISE.FDA.CDER with reference code FDA-CDER-.

8/28/2026 3:00:00 PM Eastern Time Zone.