Epidemiologist

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and compensated under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.

The Center for Drug Evaluation and Research (CDER), is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC).

This position is in the Divisions of Epidemiology (DEPI I and II). The mission of these divisions are to protect the public using epidemiologic evidence to assess the safety and effectiveness of drugs and biologics and evaluate observational methods and analytical approaches of real-world evidence for drug efficacy.

Duties/Responsibilities

As a Epidemiologist, the incumbent will be responsible for managing pre- and post-approval drug safety and efficacy review, review of epidemiologic submissions from regulated industry, overseeing a portfolio of drug products for which they are responsible for managing post-approval safety and safety signal evaluation. This may include the conduct of literature reviews, and developing and executing safety evaluations using the Sentinel System and other resources. The incumbent will:

• Provides expertise in the use of data such as computerized electronic medical records, claims, managed care data, as well as other data sources such as prospective data collection to conduct epidemiologic evaluations.
• Coordinates and conducts epidemiologic analyses and reviews required for the assessment of the safety and efficacy/effectiveness of medical products, including specification of regulatory research questions, selection of adequate population or data sources to inform regulatory questions, implementation of data management strategies and preparation of analytical datasets, development and implementation of appropriate study design and analytical methodologies, and provision of adequate interpretation of results..
• Provides technical assistance and participates fully in the scientific review of new drug and biologic applications when safety concerns are identified, or epidemiologic expertise is needed.
• Provides an evaluation of the advantages and limitations of utilizing observational population/data sources, study designs, and analytical strategies to evaluate safety concerns post-marketing, provides required assessments for issuance of post-marketing studies under the Food and Drug Administration Amendments Act (FDAAA).
• Coordinates and conducts epidemiological and statistical studies in drug safety and effectiveness, conducts and coordinates safety surveillance, signal evaluation, and risk assessment of pharmaceutical products using epidemiologic approaches.
• Prepares comprehensive reports of study protocols and results. These include discussion of the research objectives, assessment of the adequacy and validity of the data used in the analyses, assessment of the methodologies, results, and the regulatory and public health relevance of the findings.
• Disseminates results of research projects in a wide range of venues including publications, peer-reviewed journals, summaries, manuscripts, and special reports. Presents results to the scientific community at professional meetings and conferences.

How to Apply

Submit resume with cover by April 3, 2024 to: DEPI-Applications@FDA.HHS.GOV. Candidate resumes may be shared with hiring official within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.

Announcement Contact

For questions regarding this Cures position, please contact OSE-PMAS-Admin-Team@FDA.HHS.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.