Director, Division of Biostatistics, 

FDA Center for Devices and Radiological Health 

This position represents an opportunity to work in a visible, high priority program area that has the potential to influence in a substantive way the direction of medical device development at the national level.

The FDA Center for Devices and Radiological Health (CDRH) regulates medical devices and radiological health products in the United States. The Division of Biostatistics uses a wide variety of clinical trial design and analysis techniques to evaluate the safety and effectiveness of emerging technology, ranging from wrinkle fillers and artificial hearts to genetic tests, cancer screening, and robotic surgery. Evaluating such a vast array of devices requires a wide variety of statistical methodologies, and CDRH has been at the forefront of incorporating novel statistical methods such as Bayesian statistics, adaptive design clinical trials, diagnostic test methodology, and propensity scores into the medical product regulatory setting. The incumbent will provide statistical and regulatory leadership to the Division, and in addition will serve as the senior statistical advisor to the Center Director, Office Directors, and other key officials.

To learn more about the position, see our advertisement in the centerfold of the October Amstat News, or the attached pdf. To learn about the FDA and the CDRH visit: http://www.fda.gov/MedicalDevices/default.htm.

Required Qualifications: Candidates for this position must be U.S. citizens. 

Candidates must have a Ph. D in statistics or biostatistics from a school approved by a recognized accrediting body in the year of the applicant’s graduation. Applicants should be known and respected within their profession, both nationally and internationally, as distinguished individuals of outstanding competence. This position will be filled under a Title 42 (f) excepted service appointment, with a salary range of $126,245 – $250,000.

Applications will be reviewed beginning October 30, 2015 and the search will be concluded when a suitable candidate is identified. Applicants must submit a cover letter noting the intent to be considered for this position, a current curriculum vitae, bibliography, and full contact details for three references. For questions or more information, or to submit an application package, contact Tahseen Mirza at (tahseen.mirza@fda.hhs.gov) or 301-796-7645.

Gerry Gray

Deputy Director, Division of Biostatistics FDA, CDRH


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