Director (Supervisory Mathematical Statistician)

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 F.

Duties

• Provides senior technical leadership and promotes innovative, science-based, quantitative decision-making throughout the total product life cycle.
• Oversees the division's review of critical materials submitted to or produced by CDRH including IDE, PMA, 510k applications.
• Establishes priorities for the division and ensures activities align with strategic priorities, mission, and Center goals.
• Directs statistical research and collaborations involving the design, analysis, and interpretation of laboratory studies, clinical trials, and observational studies.
• Conducts risk assessments and risk/benefit analyses for medical devices.
• Exercises the full range of first and second level supervisory responsibilities.
• Plans work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work.
• Assigns work to subordinates based on priorities, considering the difficulty and requirements of assignments and the capabilities of employees.

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: National Association of Credential Evaluation Services (NACES) 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.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans’ preference does not apply to this vacancy. If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test.

Failure to comply with any of the additional assessment requirements will result in removal from further consideration. Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Required Documents

• Resume: At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed.
• A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
• USAJobs – What to Include USAJobs – Page Limit Your two (2) page RESUME showing all relevant work experience (paid and unpaid) including: duties performed; full name and address of each employer; start and end dates (month/day/year); work schedule (part-time, full-time, number of hours if intermittent); salary; and any completed education and training (program title, subject area, number of hours completed, and completion date).
• Transcripts: If the position has an education requirement or you are qualifying based on education, unofficial transcripts or a list of courses must be provided.
• See the Qualifications and Education Requirements section of this announcement.
• Professional Licensure: If the position has a licensure requirement, a copy of your professional license must be provided.
• See the Qualifications and Education Requirements section of this announcement.
• Additional Documents (if applicable): Cover Letter DD-214/ Statement of Service Disability Letter (Schedule A) Disability Letter (VA) License Other supporting documentation not listed above PCS Orders Performance Appraisal Professional Certification Resume Separation Notice (RIF) SF-15 SF-50/ Notification of Personnel Action Transcript Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.