Epidemiologist - Medical Device Epidemiology and Real-World Data Sciences Kelly Science and Clinical FSP is currently seeking an Epidemiologst for a remote opportunity supporting our Medical Device client. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. Summary: In this role, you will design and conduct real?world evidence (RWE) surveillance and safety studies to support post?market clinical follow?up activities to ensure compliance with EU?MDR requirements. You will also collaborate to identify and evaluate new real?world data sources for safety monitoring and to leverage AI-driven approaches.

• Responsibilities:Partner with other functions (e.g., Medical Safety, Clinical Research, Medical Affairs) to design and conduct observation studies using real world data to assess safety. A priority focus is on RWE surveillance studies to meet EU-MDR requirements using hospital billing data.
• Write study protocols and study reports, use a variety of analytical techniques applied to various databases, and strategize regarding research programs.
• Participate in initiatives and epidemiology training, as needed
• Demonstrate innovation and excellence as we conduct medical device surveillance studies.
• Collaborate with academic institutions, health systems, registries and/or other research partners on identifying additional data sources for medical device safety surveillance.
• Participate in various activities of medical device businesses (Surgery, Electrophysiology, Cardiovascular), the larger cross-sector Epidemiology Department (Innovative Medicine) and the Office of Chief Medical Officer.

Qualifications

• Required:An advanced degree (Master's required, Ph.D. preferred) in Epidemiology, Health Outcomes, Biostatistics, Data Science, or related field.
• 3 – 4 years of relevant experience in a related field, such as epidemiologic research in academia, contract research organization, medical device or pharmaceutical industry.
• Strong knowledge of standard statistical software (e.g. R, SQL, SAS).
• Working knowledge of applied epidemiologic methods.
• Knowledge and hands-on experience with healthcare real-world data sources (e.g., insurance claims data, electronic medical records, and hospital billing data).
• Excellent oral and written communication skills, including experience presenting to technical and lay groups.
• Preferred:Experience in medical devices.
• Experience authoring peer reviewed publications using RWD as evidenced by publication and journal articles.
• Epidemiology or related research work experience in Industry
• Experience in designing and conducting safety studies