*Applications will be reviewed on a rolling-basis.

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

The Office of Surveillance deals with a high volume of structured and unstructured data related to regulated facilities and products and has limited resources to perform manual reviews. There is a need to apply modern statistical approaches, such as data mining, machine learning and predictive analytics to analyze bigger, more complex data and deliver faster, more accurate results. The objective of this project is to research these available methods, test their application, and compare results to identify the most robust approaches.

Under the guidance of a mentor, the participant will learn to evaluate and enhance an automated (i.e., machine) language translation program, identify techniques used by other industries (e.g., automotive, retail) to monitor product performance and customer sentiment, and test the identified methods using pharmaceutical quality data. This experience will enhance their overall training and development in computer science, bioinformatics, and as a scientist.

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 six 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 either full-time (preferred) or part-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.