Epidemiologist

Summary

Kelly Science and Clinical FSP provides functional service provider solutions and is seeking an Epidemiologist to support a medical device client. The role designs and conducts real-world evidence surveillance and safety studies for post-market clinical follow-up and EU-MDR compliance, while evaluating new data sources and AI-driven approaches. The position also involves cross-functional collaboration, study documentation, analytical work, and medical device safety research.

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

Skills

• 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
• 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

Qualifications

Must Haves

• 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

Nice to Haves

• 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

Benefits

• Remote opportunity
• Full benefit options
• Medical insurance
• Dental insurance
• Vision insurance
• 401K
• Paid time off, including holiday, vacation, and sick/personal time