Regulatory Scientific Reviewer (Mathematical Statistician)

Regulatory Scientific Reviewer (Mathematical Statistician)

Department: Department of Health and Human Services

Location(s): Silver Spring, Maryland

Salary Range: $121785 - $191352 Per Year

Job Summary: 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 C FPL C.

Major Duties:

• The regulatory scientific reviewer serves as an experienced professional who has achieved mastery in core competencies and independently conducts regulatory reviews and evaluations of significant scope and complexity within their designated area of expertise with little to no supervision. The reviewer applies comprehensive scientific principles and regulatory frameworks as well as advanced knowledge of precedents and emerging scientific developments to assess data submitted by manufacturers and sponsors, determining compliance with FDA standards and regulatory requirements and making authoritative recommendations. The scientist coordinates with multidisciplinary teams, may lead technical aspects of reviews, and provides expert technical guidance on complex regulatory matters. The reviewer applies established scientific principles and regulatory frameworks to assess data submitted by manufacturers and sponsors, determining compliance with FDA standards and regulatory requirements. The reviewer coordinates with multidisciplinary teams and provides technical guidance on moderately complex regulatory matters. The reviewer conducts comprehensive evaluations of complex regulatory submissions, including detailed analysis of manufacturing practices, quality systems, clinical data (as applicable), and labeling for accuracy and completeness with authority to make independent determinations on moderately complex issues. Independently identifies potential compliance issues and safety concerns. When appropriate, takes a lead role in compliance and enforcement activities to protect consumers from unsafe, adulterated, or mislabeled products. The reviewer applies deep scientific expertise to interpret complex data and make authoritative recommendations regarding product approval or regulatory action that are typically accepted by supervisory officials. As a recognized technical expert, the reviewer provides authoritative input on regulatory decisions within their area of expertise and increasingly on related matters requiring cross-disciplinary knowledge. This includes taking a leading role in the development of review standards and criteria, contributing to precedent-setting scientific issues that inform Agency policy with recommendations that frequently establish office or division approaches, and independently preparing or contributing substantively to regulatory guidance documents. The reviewer regularly represents the Office/Center in professional forums, serves as a technical expert on complex review teams, and contributes to collaborative activities with internal and external stakeholders providing authoritative scientific perspectives.

Qualifications: In order to qualify for the Regulatory Scientific Reviewer (Mathematical Statistician) position which falls under the 1529 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/20/2026: 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 FOR THE BAND C. Have a bachelor'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 master's degree and have 3 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 1 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 0 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 6 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.

How to Apply: In accordance with Executive Order 14170, applicants are encouraged to respond to the four short, free-response, essay questions in the questionnaire. Answers to these questions are optional and will not be scored or rated. Your answers will be reviewed by the hiring manager and agency leadership if you are referred for selection consideration. You will be asked to certify that your responses are written in your own words and that you did not use a consultant or artificial intelligence (AI) tool (such as ChatGPT or Copilot). Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. To apply for positions with the Food & Drug Administration, you must have a https://secure.login.gov/ account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 03/20/2026. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://help.usajobs.gov/how-to. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Contact us at: USAJOBS - Contact us FDA's Applicant Help Desk is not able to support USAJOBS-related issues. The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://appsupport-usastaffing.opm.gov/hc/en-us. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail ERIC@fda.hhs.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12898946 so that we may assist you faster.

Application Deadline: 2026-03-20