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*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Translational Sciences/ Office of Biostatistics (OB), 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.

Our project explores using machine learning techniques to identify individuals by Pharmacokinetic (PK) profiles and to determine the similarities and differences of different PK profiles. Specifically, the project will focus on describing clustering methods and identifying what elements to consider for clustering PK profiles. We propose comparing different clustering techniques using internal PK data and simulation studies. The proposed study can potentially be used to understand and quantify the variability in drug response and to guide stratification and targeting of patient subgroups.

Under the guidance of the mentor, the participant will gain understanding of PK and machine learning techniques and will identify how to incorporate within-subject and between-subject variability of PK concentration data. The participant will also be given the opportunity to prepare a manuscript to include results and conclusions.

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 in your email.