Data Analytics for Regulatory Science Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Generic Drugs/ Office of Research and Standards (ORS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located 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.
Survival analysis is performed to analyze the expected time-to-event occurrence, such as forecasting the time to submission of an Abbreviated New Drug Application (ANDA). The Cox model has been commonly used for survival analysis; however, due to its oversimplified assumptions (e.g., linearity and proportional hazard), the Cox model is at risk of underperforming when modeling complex data (e.g., nonlinear and/or high dimension). Among other developments made to address shortcomings of the Cox model, DeepHit, a deep learning-based survival analysis is the sought-after one. We aim to conduct a systematic performance check for the DeepHit, compared to other survival models.
Under the guidance of the mentor, the participant will learn to define/identify a valid question, which should be scientifically meaningful; to design a study to check the performance of computational methods; to identify/collect correct datasets, including synthesizing data by simulations; to conduct data analysis including model construction; to evaluate performance of model and interpret results. The participant will also gain research knowledge in the regulatory environment.
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 ten 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 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 ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0717) in your email.