Epidemiologist

Tunnell Government Services•Bethesda, MD

1d•Remote

About The Position

Tunnell Government Services, Inc. is seeking an Epidemiologist to provide expert consulting services to the FDA Center for Devices and Radiological Health (CDRH). The CDRH's mission is to protect and promote public health by ensuring timely access to safe, effective, and high-quality medical devices and radiation-emitting products. This role will support the Office of Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ), which provides policy and program support for clinical trials, biostatistics, real-world evidence, and epidemiological analysis. The consultant will support medical device reviews, participate in meetings, coordinate with stakeholders, develop written reviews and reports, and execute administrative tasks related to CDRH's projects. The candidate will possess specific expertise in epidemiology relevant to evaluating the safety, effectiveness, and post-market performance of medical devices and radiation-emitting products, and analyzing clinical trial data, real-world evidence, and adverse event reports.

Requirements

Possess a doctorate in an area of study such as Epidemiology, Applied Statistics, or Public Health.
Possess several years of experience coordinating, conducting, and/or reviewing epidemiologic studies, surveys, and/or analyses to inform program and policy decisions.
Must possess a bachelor’s degree (BS) in a relevant field
5-7 years of applicable experience is required
Ability to communicate well with others using excellent written and verbal communication skills.
Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)
Must be a US Citizen or a Full Green Card holder.

Nice To Haves

An understanding of medical device regulations is preferred.
An advanced degree (MD, MS, PhD) in a related/applicable field is strongly preferred.
Advanced degrees can substitute for professional work experience

Responsibilities

Monitor medical devices already on the market to detect safety signals, assess risks, and investigate adverse events
Collaborate with biostatisticians and medical officers to review study protocols, clinical evidence, and real-world data (RWD)
Use epidemiological methods to guide policy frameworks, ensuring that patients and healthcare providers have timely access to safe and effective devices
Quantify the benefits and risks of innovative medical technologies, including AI and digital health applications
Provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions)
Participate in meetings and teleconferences
Coordinate meetings with internal and external stakeholders
Develop written reviews and correspondence
Write detailed documents and reports
Execute other administrative tasks related to CDRH’s projects