Director (Supervisory Mathematical Statistician)

About the role

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 F.

Responsibilities

• Provides senior technical leadership and promotes innovative, science-based, quantitative decision-making throughout the total product life cycle.
• Oversees the division's review of critical materials submitted to or produced by CDRH including IDE, PMA, 510k applications.
• Establishes priorities for the division and ensures activities align with strategic priorities, mission, and Center goals.
• Directs statistical research and collaborations involving the design, analysis, and interpretation of laboratory studies, clinical trials, and observational studies.
• Conducts risk assessments and risk/benefit analyses for medical devices.
• Exercises the full range of first and second level supervisory responsibilities.
• Plans work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work.
• Sets work priorities and assigns work to subordinates based on priorities, considering the difficulty and requirements of assignments and the capabilities of employees.

Requirements

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Qualifications

• 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.
• Minimum Years of Experience Requirements:
  • I have a bachelor's degree and have 7 years of comparable experience that includes managing, supervising, leading, or 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.
  • I have a master's degree and have 6 years of comparable experience that that includes managing, supervising, leading, or 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.
  • I have a Doctorate and/or J.D. degree and have 4 years of comparable experience that that includes managing, supervising, leading, or 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.
  • I have a MD, DO, DDS, DPM, or DVM degree and have 4 years of comparable experience that that includes managing, supervising, leading, or 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.
  • I have 11 years of comparable experience in comparable experience that that includes managing, supervising, leading, or 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.