Work at the Food and Drug Administration (FDA) has an impact on the lives of most Americans. This position represents an excellent career opportunity to work in a visible, high priority area that has the potential to impact the way statistics is used to advance regulatory science and development of biological products.
The Center for Biologics Evaluation and Research (CBER) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products. The Office of Biostatistics and Epidemiology (OBE) provides comprehensive statistical and epidemiological evaluation of data submitted to the Center in support of regulatory requirements and collaborates with other Offices within CBER to provide reviews and assessments of regulated biological products. OBE represents the Center on statistical initiatives and epidemiological evaluation of medical products; contributes to the development of regulatory policy; and conducts independent research on statistical and epidemiological methods for assessing the efficacy and safety of biological products. The Division of Biostatistics uses a wide variety of clinical trial designs and analyses to evaluate the products regulated by CBER including novel statistical methods such as Bayesian statistics, adaptive designs, and propensity scores.
OBE is seeking a Director for the Division of Biostatistics (DB) through the Title 42(f) hiring authority.
As a Division Director, the selected candidate is responsible for the following: planning, developing, executing, administering, coordinating, managing, and directing the Division's activities; advising key officials and stakeholders on biostatistics activities that affect major programs, projects and initiatives; collaborating with heads of other programs in CBER to negotiate, decide on, and coordinate work-related changes; advising officials with broader and higher responsibilities on problems involving the relationship of the work of the Division to other programs in the Agency; and supervising employees graded GS-12 through GS-15 (or equivalent), which includes group leaders, expert statisticians, and administrative personnel.
Applicants must meet all of the below requirements in order to be considered for this position.
BASIC REQUIREMENTS: Applicants must demonstrate that they meet the basic requirement for the 1529 occupational series which includes: A) Degree that included 24 semester hours of mathematics and statistics, of which at least 12 semester hours were in mathematics and 6 semester hours were in statistics; -OR- B) Combination of education and experience with at least 24 semester hours of mathematics and statistics, including at least 12 hours in mathematics and 6 hours in statistics, as shown in A above, plus appropriate experience or additional education.
TITLE 42(F) REQUIREMENTS: Candidates must be a U.S. Citizen and possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D. Candidates must also have professional experience and stature in their area of expertise commensurate with the duties of the position. Note: This Title 42(f) position is a permanent, excepted service position.
This position may also be filled by appointment in the U.S. Public Health Service (USPHS), Commissioned Corps.
ADDITIONAL QUALIFICATION REQUIREMENTS:
The incumbent should also have the following:
Knowledge of medical product development process;
A history of leading innovative change within an organization;
Understanding of the role of quantitative sciences throughout the medical product lifecycle;
Ability to evaluate statistical regulatory requirements;
Excellent oral and written communication skills;
Ability to build consensus and implement new programs and processes within a complex organization;
Ability to direct and supervise a budgeted staff of approximately 40 employees;
Ability to provide expert statistical consultation and advice to other Centers in FDA, to other Government agencies, and to international organizations; and
Ability to represent CBER at conference meetings with industry representatives.
Applicants must submit a cover letter noting the intent to be considered for this position, an electronic resume or curriculum vitae, bibliography, full contact details for three references, and supporting documentation (i.e. educational transcripts) to: firstname.lastname@example.org. Please reference Job Code: OBE-18-0001-ASA.
Additional Salary Information: Salary will be commensurate with education and experience. An excellent benefits package is also available.
About Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER)
The Center for Biologics Evaluation and Research (CBER) is the Center within the Food and Drug Administration (FDA) that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available ...to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.