Overview
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in Silver Spring, Maryland.
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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER’s mission is to protect and promote health by helping to ensure that these human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients who need them.
CDER’s Office of Biostatistics (OB) located in the Office of Translational Sciences at the FDA is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based quantitative decision-making throughout the drug development life cycle. We provide statistical leadership, expertise, and advice to foster the expeditious development of safe and effective drugs and therapeutic biologics for the American people.
Research Project: You will gain hands-on experience with regulatory research projects under the guidance of an expert OB mentor, utilizing real or simulated data to address statistical problems in a stimulating, collaborative, and supportive environment. Past research project areas have included modeling and simulation, missing data, noninferiority trials, multiple endpoints, adaptive designs, Bayesian design and analysis methods, estimands, meta-analyses, benefit-risk analyses, subgroup analyses, biosimilars, patient experience data, bioequivalence, quality control, cardiac safety, and data mining. Past fellows have been involved in the development of statistical methods, software tools, and new drug application databases for the analysis of pre-clinical and pre- and post-market clinical data.
Learning Objectives: You will conduct research under the mentor’s guidance but will also have the opportunity of demonstrating your skills of acting independently, preparing reports and presentations, exercising your critical thinking and collaborating with colleagues from other scientific disciplines. This is an educational and developmental program in mathematics and statistics, including biometrics and biostatistics, in which you will receive related training and opportunities to continue your education and research training, enhance your professional development, become familiar with research areas conducted at CDER, and become aware of future careers related to CDER and/or the FDA’s public health mission.
Mentor: The mentor for this opportunity is Scott Goldie (scott.goldie@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 2027. 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. The fellow is expected to primarily be on site in Silver Spring, MD.
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.
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.
Qualifications
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.
Point of Contact
Ashley
Eligibility Requirements
Degree: Bachelor’s Degree, Master’s Degree, or Doctoral Degree.
About U.S. Food and Drug Administration (FDA)
FDA's mission is to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and ensure the safety of our food supply, cosmetics, and products that emit radiation.
