The Food and Drug Administration (FDA) is seeking a Division Director for the Office of Biostatistics (OB), located in the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA. The Office of Biostatistics provides leadership, direction, policy development, and coordination to the Center for Drug Evaluation and Research (CDER) on statistical, mathematical, and computational aspects of review, evaluation, and research. Working at the FDA, you can make a difference in the lives of every American, helping to make their world healthier, safer and better. This position represents an excellent career opportunity to work in a visible, high priority program area that has the potential to alter in a substantive way the direction of drug development at the national level.
The incumbent serves as the Supervisory Mathematical Statistician and Division Director in one of the nine Division of Biometrics (DB), participating fully with the Office Director in planning, managing, organizing, and directing all of the regulatory review operations, program segment(s), functions, and activities of the division as carried out by subordinate supervisors/team leaders and a highly trained and skilled staff of professionals (mathematical statisticians and support staff) organized into subordinate organizations responsible for the regulatory review mission of the Division of Biometrics. The mission of the division is to provide comprehensive statistical and bio-mathematical services to Center programs.
The Division Director reports to the Director of the Office of Biostatistics and is a member of the Office of Biostatistics Senior Leadership Team and the Statistical Policy Council. The Office of Biostatistics is comprised of more than 230 employees, mostly holding doctoral degrees in statistics or biostatistics. The Office of Biostatistics supports the medical divisions in the Office of New Drugs, as well as review functions in the Office of Generic Drugs and across the Center in Pharmacology/Toxicology, Chemistry, Manufacturing and Controls.
Key requirements include:
Expert knowledge of FDA medical product research that involves clinical trials and/or clinical studies.
Broad experience and/or expertise in one or more of the following: survival analysis, general and generalized linear models, longitudinal data analysis, missing data methods, Bayesian methods, ROC analysis, diagnostic statistics, bioassay methodology, computational statistics, propensity scores, adaptive designs, genetic statistics, or development of statistical methodology.
Expert knowledge of broad areas of mathematical or statistical theory, including techniques to originate and develop new statistical methods.
Ability to provide consultation and/or analyze data from studies utilizing sophisticated analytical techniques, advise the staff on appropriate interpretation and use of statistical analysis and statistical packages, and perform standard analysis of research studies.
Expert knowledge of the principles, theories and applications of statistical methodology as applied to study design and analysis in the supported program area.
Regulatory knowledge necessary to serve as an authority on the review and conduct of various studies in the supported program area; for example, pertinent FDA laws, regulations and guidelines in the supported area.
Expert knowledge required to provide sound and relevant statistical analysis of pre-market and post-market data and to provide rapid response to medical reviewers or investigators.
Ability to direct consensus and alignment within a multi-disciplinary organization and experience in leading innovative change.
Ability to direct/supervise staff members, including scientific, professional, technical, administrative, and clerical support personnel assigned, ranging in levels from senior executive to entry levels.
Ability to provide expert consultation and advise on biostatistics to other Centers in FDA, to other Government agencies, and to international organizations.
Exceptional written and oral communication skill.
Minimum Education Requirement:
A doctoral-level degree that meets the Mathematical Statistics Series 1529 education requirements in accordance with the Office of Personnel Management (OPM) qualification standards. Transcripts are required as supporting documentation.
The candidate must possess a doctoral-level degree in Statistics or Biostatistics from an accredited institution of higher learning, including: Ph.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.
Ethics Requirements: This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Public Financial Disclosure Report (OGE 278) and will require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made.
Security and Background Requirements: A background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action.
Telecommuting is allowed.
Internal Number: 1529
About U.S. Food and 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.
Under the Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), the Office of Biostatistics (OB) is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle. To support CDER’...s mission, we provide statistical leadership, expertise, and advice to ensure that safe and effective drugs are available to the American people.
FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.