Division Director (Supervisory Mathematical Statistician)

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The mission of the Center for Devices and Radiological Health (CDRH or Center) is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. The Office of

Product Evaluation and Quality (OPEQ) assures patients have access to high quality, safe, and

effective medical devices and products throughout the total product lifecycle (TPLC) by implementing program areas through which medical devices are evaluated or cleared for clinical investigations and marketing.

The Office of Clinical Evidence and Analysis (OCEA or Office) is responsible for the development of policy related to CDRH’s oversight and regulation of clinical trials and other sources of clinical evidence for medical devices. This includes development and implementation of policies related to human subject protection, good clinical practice, and appropriate collection of real-world evidence (RWE).

Duties/Responsibilities

Reporting directly to the OCEA Deputy Office Director, the Division Director will provide senior leadership and promotes innovative, science-based, quantitative decision-making throughout the total product lifecycle for both therapeutic and diagnostic devices. The Division Director will also perform the following duties:

• Oversee the review of IDE, PMA, 510K applications, standards, and guidelines for statistical validity, consistency, and interpretation.
• Work in partnership with the Deputy Office Director and in close coordination with leadership of other biostatics divisions.
• Provide oversight for original statistical research or collaborations directed towards the design, analysis, and interpretation of laboratory studies, clinical trials, and observational studies.
• Collaborate with statisticians in other Centers and Agencies on methodological issues, statistical research.
• Set priorities and ensures all activities are aligned to and serve to advance OCEA’s Strategic Priorities, OPEQ’s mission and vision, and the Center’s goals.

Supervisory Responsibilities

• Provide leadership across a multi-disciplinary program, managing subordinate staff and with support of supervisory staff assigned across the teams that comprise the division.
• Provide guidance to managers and staff on policies and programmatic support.

How to Apply

How to Apply: Submit resume or curriculum vitae, transcripts with cover letter by September 18, 2024, to CDRHRecruitment@fda.hhs.gov. Compile all applicant documents into one combined document (i.e., Adobe PDF). Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: OCEA/DCEA5/Division Director

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If

selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.

Announcement Contact

For questions regarding this Cures position, please contact CDRHRecruitment@fda.hhs.gov

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.