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 5 , Band G.

Duties

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• 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.

Requirements

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Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.

Qualifications

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:

1. Scientific, Technical, and/or Professional Fields
2. 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.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Education Requirement:

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

TRANSCRIPTS (Required): Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

1. National Association of Credential Evaluation Services (NACES)
2. Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Additional information

Additional Conditions of Employment:

• Pre-employment physical required: No

• Drug testing required: No

• License required: No

• Mobility agreement required: No

• Immunization required: No

• Bargaining Unit: No

• Telework eligible position: Telework is at the discretion of the supervisor.

• Financial disclosure statement, SF-278, required: Please be advised that this position is subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.

Additional Information:

• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.