Office Director (Supervisory Mathematical 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 5 , Band G.
Major duties
The Director for the Office of Biostatistics and Pharmacovigilance (OBPV) provides comprehensive statistical and epidemiological evaluation of data submitted to the Center in support of regulatory requirements. Represents the Center, Center Director, and FDA, Public Health Service, Department, industry, and national/international meetings on statistical/epidemiological evaluation of medical products and safety; makes policy commitments and recommendations. Contributes to the development of regulatory policy in areas relevant to the disciplines of biostatistics and epidemiology, such as post-marketing surveillance and the design, conduct and analysis of studies to evaluate medical products. Conducts independent research relating to statistical and epidemiological methods for assessing the efficacy and safety of biological products, and for assuring the quality and consistency of their manufacture. Establishes and conducts a training program for statistics, epidemiology and clinical trial design for Center staff and participants in science workshops. Develops, maintains, and monitors a database for adverse reactions of biological products to analyze trends and safety issues; organizes reports and coordinates analyses of adverse reactions with the Center. Assists in the design, implementation, and monitoring of Phase IV post marketing surveillance programs. Serves as expert advisor in his/her specialty during the initiation and formulation of regulatory programs and regulations. Testifies as expert witness at court hearings. Collaborates with Center components to provide reviews, assessments, and risk assessments of regulated biological products.
What you need to qualify
In order to qualify for the Office Director (Supervisory Mathematical Statistician) position which falls under the 1529 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/27/2026: The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both. Minimum Qualifications: To qualify for a Band G Office Director (Supervisory Mathematical Statistician) position, you must meet the Education Requirement listed in the Education section below. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Minimum Qualifications. Supervisory Responsibilities The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review. Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same. Organizational Management: Manages an Office. Program Management: Runs a multi-disciplinary program in the Center. May run two or more smaller, multi-disciplinary programs in the Center. Identifies specific activities needed to achieve desired outcomes. Organizational staffing patterns are primarily homogeneous, but may also have staff in various scientific, professional, technical, or administrative occupational series. Resource Management: Monitors and reports on resources needed to run an Office or a multi-disciplinary program in the Center.: Human Capital Management: Identifies employee competencies necessary to meet organizational capabilities goals. Provides reasonable accommodations needed to best utilize qualified people with disabilities. This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes.
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