*Applications will be reviewed on a rolling-basis.
Multiple research opportunities are available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Clinical Pharmacology (OCP) 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 project will utilize a machine learning algorithm to predict clinical outcome after treatment (including efficacy and toxicity). The participant will pool data from relevant clinical trials, then use algorithms to explore the relationship between baseline patient factors (e.g., demographic information, clinical and lab data) and clinical outcome. Models will be built to describe the relationship and make predictions. Under the guidance of a mentor, the participant will learn about drug development, regulatory sciences, principles of precision medicine and clinical data analyses.
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.