The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the nation’s food supply, cosmetics, and products that emit radiation.
The Center for Biologics Evaluation and Research (CBER) is responsible for regulation of biologic products including vaccines; allergenics; blood; blood-derived products; tissues; and cell, gene and advanced therapeutics.
This position is in the Immediate Office of the Director (IOD), Office of Biostatistics and Epidemiology (OBE), CBER. The position is within the CBER Sentinel Central Team. The functions of OBE are listed below:
• Provides comprehensive statistical and epidemiological evaluation of data submitted to the Center in support of regulatory requirements.
• Collaborates with other Center components to provide reviews and assessments of regulated biological products. Represents the Center within the agency, the Public Health Service, the Department and elsewhere regarding initiatives relating to the statistical and epidemiological evaluation of medical products, including the evaluation of product safety.
• Contributes to the development of regulatory policy in areas relevant to the disciplines of biostatistics and epidemiology, such as post-market surveillance, design, conduct, and analysis of studies to evaluate medical products.
• Conducts independent research relating to statistical and epidemiological methods for assessing the effectiveness and safety of biological products, and for assuring the quality and consistency of their manufacturing.
As a member of the CBER Sentinel Central Team, the candidate will collaboratively work with OBE and CBER staff to identify key post-market biologic safety questions to be addressed by CBER Sentinel studies, and coordinate and formulate design of appropriate studies and analyses.
Major Duties include:
Lead design and execution of simple and complex observational studies using large-scale health care data and interpretation of study results.
• Design, plan, and execute epidemiologic studies and analyses, and investigations relating to the post-market safety and effectiveness of biologics and participate with senior level staff in various aspects of the study process. This includes specification of study question, hypothesis, design, selection of appropriate study population and databases, performance of statistical analytic methods, and interpretation of the results. Efforts may include conducting searches or reviewing existing literature and databases in a specialty area, preparing and presenting summaries for a variety of purposes, and designing questionnaires and other data collection instruments.
• Identify and analyze public health issues related to biologics safety and effectiveness and their impact on public health policies. Identify epidemiologic study reports and databases relevant to the post-market safety assessment of biologics.
Utilize results of observational studies to support safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics regulated by CBER.
• Serve as a recognized expert in the review and analysis of post-market safety and effectiveness issues related to biologics. Responsibilities include developing public health policy and objectives, appraising programs, and initiating requirements for various post-market epidemiologic studies. Assignments cover complex public health issues. Efforts may include analysis and evaluation of biologics safety and effectiveness data based on scientific information from clinical trials, electronic health records, observational studies, and other sources. The position may require providing epidemiologic advice to resolve technical problems that may result in significant barriers to program or project delivery.
Participate in building the infrastructure for an active surveillance system of biologics using large-scale administrative claims and electronic health record (EHR) data sources from a variety of sources.
• Participate in and contribute to top level Office, Center, Agency, PHS, and Department discussions, meetings and conferences related to CBER Sentinel including the formulation and strategic development of OBE and CBER Sentinel organization, policies, programs, projects, and initiatives. These matters pertain to the deployment of the CBER’s system for identification and evaluation of safety signals and concerns for all biologic products regulated by CBER.
• Doctoral degree in epidemiology
• Strong analytical and quantitative skills
• Solid writing competency
• Advanced oral and written communications
• Experience working with large-scale health-care databases
Internal Number: FY19Epidem
About U.S. Food & Drug Administration
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.