FDA Competing Risk Analyses Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs/Division of Cardiorenal Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Competing risk issues arise when analyzing multiple (recurrent)-event data which are commonly collected in cardiovascular and renal studies to support drug approval. Traditional time-to-first-event analyses may not be optimal in terms of efficiency in detecting treatment effect and interpretation of analyses results since only partial data are used. There is a need to examine the statistical methods for handling competing risk issues in the public literature and identify any more desirable methods. The identified methods will be further tested, tailored and improved to address our specific concerns. This effort will help FDA reviewers to provide scientifically sound feedback on design and analysis of cardiovascular and renal studies.
Under the guidance of a mentor, the participant will receive training related to the following topics:
- the fundamentals of how FDA/CDER reviewers perform extensive literature reviews and make a concise summary
- the cardiovascular/renal trial data structure and how it maps onto study design and results
- development of R scripts to obtain, summarize and visualize the cardiovascular/renal trial data
- deployment of R scripts and Shiny-based web applications to implement the desirable statistical methods
Qualifications
The qualified candidate should be currently pursuing or have received a doctoral degree in Bioinformatics, Statistics, or a related field. Degree must have been received within five years of the appointment start date.
Preferred skills:
- Familiarity with survival analyses and R/SAS/Python programming
- Previous research/knowledge in developing statistical approach for handling competing risk issues
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0508) in your email.