Regulatory Scientific Reviewer (Mathematical Statistician)

Full Job Description

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.

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. 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.