Biostatistics and Data Analytics Fellowship with the U.S. Food and Drug Administration (FDA)

https://www.zintellect.com/Opportunity/Details/FDA-CDER-2019-0339

An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland.

CARE Sentinel, a project in the Office of New Drugs (OND)/Office of Drug Evaluation II (ODE II), will examine clinical questions about Chronic Obstructive Pulmonary Disease (COPD) using the Sentinel Distributed Database system, a large distributed healthcare claims database. The project will focus on creating precise and robust programmatic definitions of obstructive lung disease cases, clinical endpoints, and medication use, for purposes of COPD queries in the Sentinel database. The project will examine access to Sentinel and the applicability of available tools for querying the database for medication efficacy trial designs. The outcome of interest will be descriptive statistics that define and characterize the sample space for COPD in Sentinel including rates of exacerbations, hospitalizations, medication use, and disease-specific covariates to facilitate answering clinical questions.

Under the guidance of a mentor the participant may be involved in:

• researching and learning about prior healthcare claims data analyses
• understanding strengths and limitations and how they apply to Sentinel data
• exploring respiratory disease definitions, associated clinical endpoints, and medication use in Sentinel
• providing statistical models to answer clinically impactful questions in respiratory disease using Sentinel data

Qualifications

The qualified candidate should be currently pursuing a master's or doctoral degree, or have received a master's or doctoral level degree in the relevant fields. Degree must have been received within the last 5 years before the appointment start date.

Familiarity with biostatistics or bioinformatics including scientific computing (programming in SAS or other languages) and healthcare data analysis is desired. A familiarity with data analysis of healthcare claims databases including developing statistical models of prospective and retrospective clinical studies is also desired.

This opportunity is available to U.S. citizens, legal permanent residents, and foreign nationals.

The FDA is actively reviewing applications and is looking to fill this opportunity as soon as qualified applicants are identified.

For a full description of this opportunity and to submit your application, visit https://www.zintellect.com/Opportunity/Details/FDA-CDER-2019-0339.

If you have any questions, please send an email to FDArpp@orau.org.