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 theTitle 21 Pay Table 2, Band F.

Duties

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• 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.

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.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• A one year supervisory probationary period may be required.

Qualifications

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:

1. 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
2. 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.

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.

TRANSCRIPTS: 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

The application limit, if applicable, for this advertisement is: N/A

Additional Conditions of Employment:

• Pre-employment physical required: No
• Drug testing required: Yes
• 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, OGE-450, required: Please be advised that this position may be 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.