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Research Project Description

Uncertainty Analysis Fellowship
Division of Pharmaceutical Analysis
Office of Pharmaceutical Science
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
St. Louis, MO

FDA-CDER-2014-0023

Project Description:

A fellowship opportunity is currently available in the Division of Pharmaceutical Analysis (DPA) within the Office of Pharmaceutical Science (OPS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) in St. Louis, Missouri.

Under the guidance of a mentor, the selected participant will aim at determining how uncertainty analysis can be used to develop a robust and reliable design space by defining a confidence band for a proposed design space. S/he will perform uncertainty analysis using Monte Carlo simulation and other statistical tools. Experience with this sort of data analysis will better prepare FDA reviewers to evaluate applications that contain design space that are determined on the basis of multivariate design of experiments. The participant will develop computer programs to implement Monte Carlo simulation for analyzing process models. These programs will utilize the Visual Basic for Applications platform within Microsoft Excel and @Risk Monte Carlo add-in for Excel.

The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for two months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. Proof of insurance must be provided to participate in this program. The appointment is full-time at FDA in the St. Louis, Missouri area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

Qualifications:

An undergraduate student with least two years of college chemistry, physics, engineering, applied mathematics or other related disciplines and who is in good standing enrolled at an accredited U.S. college or university. Verification of enrollment will be required each semester.

How to Apply:

To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0023 in all communications.