*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Pharmaceutical Quality/ Office of Quality Surveillance (OQS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) 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.

OQS deals with a high volume of structured and unstructured data related to regulated facilities and products and has limited resources to perform manual reviews. Through applying modern statistical approaches, such as data mining, natural language processing and deep learning, complex data and large data can be studied to deliver faster, more accurate results. This project is to research available methods, test their application, and compare results to identify the most robust approaches to enhance comprehensive quality surveillance.

Under the guidance of the mentor, the participant will learn to work with these complex datasets. These include, but are not limited to, missing data, longitudinal data, and datasets with more predictors than observations. 

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 five months, 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 can be full-time or part-time, depending on the candidate’s availability, 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.