A research opportunity is available in the Division of Pulmonary, Allergy, and Critical Care (DPACC), Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
As part of FDA’s broader initiative to use real world data from the Sentinel Distributed Database to inform regulatory decision-making, DPACC proposes to use Sentinel data to answer clinical effectiveness questions in obstructive lung disease. This project will perform analyses of drug administration data in Sentinel data. Combined with clinically impactful effectiveness endpoints of disease exacerbation and hospital utilization data, this could inform regulatory effectiveness decisions on new indications, new efficacy claims, and new populations for pulmonary drugs using real world evidence.
The participant will have an opportunity to learn from a multidisciplinary team of experts including FDA physicians, pharmacoepidemiologists, and clinical pharmacologists with experience in real world evidence, data science, and regulatory decision-making. The participant will gain experience in the design, conduct, and interpretation of real world evidence (RWE) observational studies.
The qualified candidate should be currently pursuing or have received a master’s or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
- Familiarity with biostatistics or bioinformatics including scientific computing (programming in SAS or other languages) and healthcare data analysis
- Familiarity with epidemiological/pharmacoepidemiological study design and analysis using observational data resources
- Familiarity with healthcare claims databases including measuring exposures and outcomes and developing statistical models
APPLY HERE: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2021-0661
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