OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY (OBE)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
Work at the Food and Drug Administration (FDA) has an impact on the lives of every American. 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.
CBER is seeking Mathematical Statisticians with knowledge of biological applications. Positions are available that will offer the opportunity for research and statistical collaboration in the development and evaluation of preventive vaccines, blood products, and advanced therapeutics such as gene therapies and cellular therapies. Expertise may be applied in areas such as innovative clinical trial design, biomarker development and qualification, meta-analysis for medical product safety, and clinical trial data standards and statistical computing. These positions will be filled using the Title 42(g) hiring authority.
CBER Mathematical Statisticians work in an environment dedicated to public health and upholding the highest scientific standards in review and research involving new biological products. Mathematical Statisticians are responsible for assessing proposed new design and analytical approaches, for assessing whether completed clinical studies support the safety and effectiveness of vaccines, blood products, and advanced therapeutics, and for developing innovative scientific approaches to evaluate often cutting-edge medical technologies. They collaborate with medical colleagues and expert laboratory scientists on the development of scientific and regulatory policy, and frequently have the opportunity to represent CBER in collaborations with outside groups. Good written and oral communication skills are essential. The successful candidate will interact extensively with other FDA scientists and reviewers, industry scientists, and scientists in other government agencies and in academia.
QUALIFICATIONS: One year probationary period may be required; Official transcripts required; Ph.D. or equivalent doctoral degree (M.D., D.V.M., etc.) required. Applicants must demonstrate that they meet the basic requirement for the desired occupational series below.
Mathematical Statistician, RG-1529: 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- Combination of education and experience -- 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.
This position may also be filled by appointment in the U.S. Public Health Service (USPHS), Commissioned Corps. To learn more information about the FDA and CBER visit: http:www.fda.gov/BiologicsBloodVaccines/default.htm.
SALARY: Salary will be commensurate with education and experience. An excellent benefits package is also available.
LOCATION: Silver Spring, MD
HOW TO APPLY: Submit electronic resume or curriculum vitae, references, and cover letter in which you describe your qualifications and career goals to firstname.lastname@example.org. Please reference Job Code: OBE-18-0002-ASA. This announcement will remain open until filled; however, for best consideration, please submit your resume by January 31, 2018.
Additional selections may be made within the same geographical area FDA-wide.
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