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FDA Quantitative Biomarkers Fellowship

*Applications will be reviewed on a rolling-basis.

A research opportunity is currently available with the Office of the Commissioner (OC) Office of Women's Health (OWH), U.S. Food and Drug Administration (FDA). The project will be located at the Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL) located in Silver Spring, Maryland.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes public health by assuring the safety and effectiveness of drugs, vaccines and medical devices. The Office of Science and Engineering Laboratories (CDRH/OSEL) accelerates patient access to innovative, safe and effective devices through best-in-the-world regulatory science.

The Division of Imaging, Diagnostics, and Software Reliability (DIDSR) develops methods for evaluating emerging medical imaging systems. Our research programs directly impact FDA’s regulatory assessments in areas including:
  • Artificial Intelligence (AI)/ Machine Learning (ML)
  • whole slide images (WSI) and digital pathology 
  • Extended-reality (AR/VR) devices 
  • Clinical trial design 
  • In silico trials 
  • Imaging physics

The selected participant will collaborate closely with a multidisciplinary research group (engineers, physicists, and clinicians) to develop quantitative biomarkers for the evaluation of bone health using radiomics and machine learning. The project aims to design and validate a realistic computational model of trabecular bone. The phantom will be used to develop CT-based texture biomarkers for assessing fracture risk in osteoporosis and for monitoring the response to osteoporosis drugs. Additionally, the phantom will be 3D-printed to aid in the evaluation of novel high-resolution CT scanners.

Under the guidance of a mentor, the participant will be involved in the following activities:
  • Phantom/biomarker development efforts will include:
  • Modeling and simulations
  • Image analysis using radiomics and machine learning
  • 3D printing
  • Mechanical testing
  • Learn about regulatory science development at the FDA
  • Contribute to the Agency’s regulatory efforts by providing technical expertise
  • Disseminate findings and regulatory science tools in conferences and peer-reviewed paper publications

Anticipated Appointment Start Date: 2021

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 initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

If you have questions, send an email to Please include the reference code for this opportunity (FDA-OWH-2022-01) in your email.