FDA Machine Learning Precision Medicine Fellowship
*Applications will be reviewed on a rolling-basis.
Multiple research opportunities are available in the Office of Translational Sciences (OTS)/ Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) 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. This work covers more than just medicines.
The same drug given at the same dose can result in different clinical outcomes in different patients. All kinds of intrinsic and extrinsic factors can have an impact on the clinical outcome after treatment. This project will use machine learning to predict clinical outcomes based on baseline patient factors, and therefore help to find the right drug at the right dose for each patient.
Under the guidance of the mentor, the participant will learn regulatory framework, methodology, and approaches for drug evaluation. The participant will also learn methods and approaches for data analyses of clinical trials datasets.
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 ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.