*Applications will be reviewed on a rolling-basis.
A research opportunity is available at the US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs/Office of Drug Evaluation II located in Silver Spring, Maryland.
A project proposes to create a database using the control arm of completed diabetes Cardiovascular Outcomes Trials (CVOT); investigate the database to better understand the effectiveness and safety of older antidiabetic drugs; interrogate the database to characterize expected event rates in various subgroups of diabetic patients [including myocardial infarction, stroke, cardiovascular deaths, pancreatitis, amputations, severe hypoglycemia, cancers (pancreatic, thyroid, other)]; and inform future enrichment strategies and passive surveillance activities.
Under the guidance of a mentor the participant may be involved in: evaluation of available diabetes cardiovascular outcomes trials to identify trials with databases appropriate for integration; conduct standardization of identified databases and integrate; conduct analyses exploring effectiveness and safety of older antidiabetic drugs; and characterize expected event rates of adverse events of special interest in various sub-populations of patients with T2D.
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.
The qualified candidate should be currently pursuing or have received a bachelor’s, master’s or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0550) in your email.