Deputy Office Director (Supervisory Statistician)
What you'd do
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.
Major duties
Serves as top scientific and technical expert and advisor and is nationally and internationally recognized authority in professional healthcare and medical related work spanning multiple disciplines with the health sciences. Provide scientific and technical leadership and guidance on regulations and policy issues, and federal laws (including the Food, Drug, and Cosmetic Act). Oversee OCEA regulatory and scientific work including developing policy and program support regarding clinical evidence, supporting device reviews that require expert clinical and real-world evidence analysis, and providing data infrastructure, management and analysis for clinical and real-world evidence. Provide scientific and technical consultation to the OCEA Director and other high-level officials in CDRH, FDA, PHS and HHS on program status, plans, trends and significant problems. Leads, manages and sets strategy for the OCEA. Ensures that OCEA activities are aligned with the goals and priorities of OPEQ. Supervisory Responsibilities: Provides technical, policy and administrative leadership, supervision and direction to the subordinate staff of the Office through subordinate supervisors. Exercises the full range of first and second-level supervisory responsibilities. Exercises significant responsibilities in dealing with officials of other units or organizations, or in advising management officials of higher rank. Works with the Office Director on the development, establishment, and clearance of goals, objectives, and strategic plans for the Office.
What you need to qualify
In order to qualify for the Deputy Office Director (Supervisory Statistician) position which falls under the 1530 occupational Series, you must meet the following requirements by 11:59 pm EST on 08/24/2026: Basic Qualification Requirements: Degree: that included 15 semester hours in statistics (or in mathematics and statistics, provided at least 6 semester hours were in statistics), and 9 additional semester hours in one or more of the following: physical or biological sciences, medicine, education, or engineering; or in the social sciences including demography, history, economics, social welfare, geography, international relations, social or cultural anthropology, health sociology, political science, public administration, psychology, etc. Credit toward meeting statistical course requirements should be given for courses in which 50 percent of the course content appears to be statistical methods, e.g., courses that included studies in research methods in psychology or economics such as tests and measurements or business cycles, or courses in methods of processing mass statistical data such as tabulating methods or electronic data processing. or Combination of education and experience -- courses as shown in A above, plus appropriate experience or additional education. The experience should have included a full range of professional statistical work such as (a) sampling, (b) collecting, computing, and analyzing statistical data, and (c) applying statistical techniques such as measurement of central tendency, dispersion, skewness, sampling error, simple and multiple correlation, analysis of variance, and tests of significance. Minimum Qualifications: Comparable experience is experience that equipped the applicant with the knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The relevant experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience). Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. 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 7 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have a master's degree and have 6 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have a Doctorate and/or J.D. degree and have 4 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have a MD, DO, DDS, DPM, or DVM degree and 4 years of experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have 11 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; Serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; Oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Before you apply
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