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 responsible for the development of policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.
Meet one of the faces behind CDRH here.
Position Summary: As an Epidemiologist in OCEA’s Clinical Evidence Outcomes Research Team within DCEA1, you will analyze postmarket device and diagnostics safety and effectiveness data based upon scientific information from clinical trials, electronic healthcare records, administrative claims, and other medical databases/registries. You will evaluate data collection, perform data quality assessments, identify inadequacies and limitations of data and data utilization methods used to study epidemiological problems and issues.
Duties/Responsibilities: The Epidemiologist also performs the following duties:
- Design, plan, and execute observational studies, epidemiologic analyses, surveys, and investigations related to the post marketing medical device safety and participates with other senior level staff in various aspects of the study or survey design process.
- Provides expert scientific, technical, and regulatory support and direction to colleagues in response to questions related to the assessment of relevancy and reliability of real-world data for real-world evidence generation.
- Plan, direct, and review the technical evaluation and research of the team in all areas of medical device and radiation-emitting electronic products.
- Determine the adequacy of information submitted and the thoroughness of data contained in scientific protocols, findings of studies or medical device evaluations submitted to the Agency by the regulated industry.
- Collaborate and prepare comprehensive, concisely written reviews regarding scientific protocols, findings of studies or medical device evaluations.
Basic Qualifications: Applicants must meet the specific qualification requirements of the following applicable occupational series: General Health Scientist (0601).
- 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:
- Reviewing quality, clinical, scientific, and other data in support of a variety of medical device and radiological health programs.
- Advising on the adequacy of research study documentation, protocols, observational study design, methodologies and epidemiologic analyses.
- Medical device evaluation and/or interpretations of results.
- Managing, directing or overseeing the work of a working group or leading a project.
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).
Conditions of Employment:
- One-year probationary period may be required.
- This position is for a two-year appointment and will be filled through FDA’s Staff Fellowship Program
- Background and/or Security investigation required.
- All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
- 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-DCEA1-040” in the email subject line.
- Email applicant package to CDRHRecruitment@fda.hhs.gov .
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.