This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 2, Band D.
In order to qualify for the Mathematical Statistician position which falls under the 1529 occupational Series, you must meet the following requirements by 11:59 pm EST on 06/13/2025: Basic Qualification Requirements: Have a bachelor's degree or higher in mathematics, statistics or in a related quantitative science field. Degrees in math education are not related. The degree must be from an accredited program or institution. OR Have comparable experience performing (1) scientific or regulatory review work that involves designing, developing, and adapting mathematical methods and techniques to statistical processes or (2) research that relates to the basic theories and science of statistics. AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and have 5 years of comparable experience performing (1) scientific or regulatory review work that involves designing, developing, and adapting mathematical methods and techniques to statistical processes or (2) research that relates to the basic theories and science of statistics. OR Have a master's degree and have 4 years of comparable experience performing (1) scientific or regulatory review work that involves designing, developing, and adapting mathematical methods and techniques to statistical processes or (2) research that relates to the basic theories and science of statistics. OR Have a Doctorate and/or J.D. degree and have 2 years of comparable experience performing (1) scientific or regulatory review work that involves designing, developing, and adapting mathematical methods and techniques to statistical processes or (2) research that relates to the basic theories and science of statistics. OR Have a MD, DO, DDS, DPM, or DVM degree and have 2 years of comparable experience performing (1) scientific or regulatory review work that involves designing, developing, and adapting mathematical methods and techniques to statistical processes or (2) research that relates to the basic theories and science of statistics. OR Have 7 years of comparable experience performing (1) scientific or regulatory review work that involves designing, developing, and adapting mathematical methods and techniques to statistical processes or (2) research that relates to the basic theories and science of statistics. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Serves as a nationally authoritative regulatory review scientist, providing technical leadership and guidance for regulatory activities in the areas of vaccines, blood products and cellular, tissue and gene therapies. Performs Reviews of IND and IDE submissions, 510(k) applications and BLA, NDA and PMA submissions and supplements, especially those related to vaccines, cancer immunotherapies, leukemia, cell therapies, and rare diseases including inherited blood disorders. Provides recommendations to CBER review organizations, review scientists, and the regulated industry. Represents the Center at local, state, and national meetings on statistical matters concerning OVRR, OBRR, and OTP-related products. Determines the adequacy of statistical data and analyses submitted by an applicant regarding the safety and effectiveness of a regulated vaccine or blood or advanced therapy product. Participates in meetings between the Center and regulated industry and advises on adequacy of statistical aspects of study plans and product development. Participates in activities of professional societies regarding the design, conduct, and analysis of regulated clinical trials, and other related statistical methodology. Represent the agency at special conferences, hearings, etc. with industry as well as the professional community, and may serve on committees, organize sessions, give oral or poster presentations, etc. Confer with other federal government agencies on joint projects and programs, mutual problems, and areas of interest, etc.