Application Period: October 4, 2021 through November 3, 2021
Salary: Salary is commensurate with education and experience.
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 CDRH 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. OCEA is dedicated to providing policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.
Position Summary: As a Mathematical Statistician (Staff Fellow) in OCEA’s Division of Clinical Evidence and Analysis 2 (DCEA2), you will provide statistical support for the design and analyses of studies and serve as an expert advisor to CDRH/OCEA and to other Government agencies in areas relating to the development and application of statistical techniques to research in the medical devices.
Duties/Responsibilities: The Mathematical Statistician (Staff Fellow) also performs the following duties:
Use a variety of statistical methodologies in the review and evaluation of medical device and radiation-emitting electronic products.
Determine the adequacy of information submitted and the thoroughness of statistical analyses completed regarding the scientific protocols and findings of studies submitted to the Agency by the regulated industry.
Collaborate and prepare comprehensive, concisely written reviews regarding scientific protocols and findings of studies.
Basic Qualifications: Applicants must meet the specific qualification requirements of the following applicable occupational series: Mathematical Statistics (1529).
Required Specialized Experience and Qualifications: To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which is equivalent to the following:
Performing statistical reviews to help refine protocols for medical product studies including but not limited to pivotal clinical studies, real world evidence synthesis, diagnostic device evaluation and epidemiologic studies; and
Advising on the adequacy of study documentation, protocols, methodologies, data analyses, and/or interpretations of results; and
Utilizing a variety of statistical methodologies for a comprehensive assessment of medical product safety and effectiveness.
Additional Qualifications: To qualify as a Staff Fellow, you must: be a US Citizen, Permanent Resident, or Non-Citizen with residency status in the U.S., three (3) out of the last five (5) years; possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.. (In limited instances non-doctoral candidates, and/or candidates with less experience may be acceptable).
This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office.
How to Apply: Prior to applying, please see the following instructions:
Documents to submit: electronic resume or curriculum vitae, cover letter describing why you are uniquely qualified for this, and copy of transcripts
Compile all applicant documents into one combined document (i.e. Adobe PDF)
Include Job Reference code “2020-OCEA-DCEA2-043” in the email subject line.
HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
About U.S Food and Drug Administration, Center for Devices and Radiological Health
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.