The Food and Drug Administration (FDA) is seeking a Deputy 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.
Deputy Division Directors in the Office of Biostatistics at FDA’s Center for Drug Evaluation and Research (CDER) partner with the respective Division Directors to lead groups of highly skilled statisticians in all aspects of drug evaluation to which statistics pertains. Qualified candidates will be sought after experts in the field of statistics who consult with international regulators and colleagues in the regulated industry on statistical innovation related to drug development and regulatory science. Deputy Division Directors guide statistical staff in consistently advising the regulated industry with respect to appropriately applied statistical methods and act as senior statisticians confirming agency actions on regulated products. The successful candidates will lead and mentor statisticians in collaborative and methodologic research as it applies to the therapeutic areas their respective divisions support.
The incumbent is a nationally and internationally recognized expert consultant on statistical problems who interacts with national, international, public and private organizations to identify common statistical problems and areas of mutual interest associated with the regulation of drug and biologic products.
As the Deputy Division Director, the incumbent is responsible for:
Serves as an expert advisor to the CDER senior management and other research teams relating to the development and application of statistical techniques to the evaluation of drug and biologic products.
Makes recommendations to senior officials on critical areas where new statistical methods can be integrated into the review process.
Collaborates on a national level with scientists, engineers, and other professionals on a wide range of statistical, technical, and regulatory issues.
Coordinates with the Director in organizing work, establishing priorities, and administering the division operations. This includes operating through the team leader(s) to render guidance on policy and administrative matters and taking responsibility for the productivity of the division and quality of work product within the division, particularly as it pertains to clinical outcome assessments (COAs), biomarker qualifications, and complex adaptive and Bayesian designs.
Participates with the Director in the process of regulated product evaluation and regulatory decision recommendations regarding NDA’s, BLA’s, and other type of submissions pertaining to drug and biologic products handled by the division. Advises the Office Director, Center Director and other FDA officials on the statistical aspects of FDA’s regulatory responsibilities in the areas of drug and biologic products as put forth in the Federal Food, Drug and Cosmetic Act. Establishes statistical policy for the Center.
Provides expert mathematical and statistical consultation to and collaboration with higher level scientists and/or engineers within the FDA and CDER and is responsible for selecting and implementing appropriate methods of data collection, summary, and analysis. Supervises and guides divisional staff to achieve these ends.
Interacts with internal and external groups to determine the most critical areas for new statistical regulatory initiatives and the most effective rapport with industry, academia, appropriate Federal agencies, and national or international research and regulatory agencies on study design and statistical issues.
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.
Key requirements will include:
Extensive knowledge of drug development.
Thorough knowledge of applicable ICH and FDA guidance documents and federal regulations that apply to marketing of drugs and therapeutic biological products.
Expert level knowledge of statistical methods applicable to clinical trials and drug studies
Experience leading scientific staff.
Experience interpreting federal regulations and guidelines for use as parameters for scientific investigations.
Experience evaluating the statistical aspects of drug studies and clinical trials.
Experience performing collaborative and methodologic statistical research.
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.
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.