Epidemiologist - EUMDR Safety Group

Kelly Science, Engineering, Technology & Telecom; United States; À distance; USD 110 000 - 155 000; Plein temps

Résumé du poste

Kelly Science, Engineering, Technology & Telecom is seeking an Epidemiologist for Medical Device Epidemiology and Real-World Data Sciences. This remote role focuses on real-world evidence to support post-market surveillance and EU-MDR compliance, with collaboration across safety, clinical research, and regulatory teams.

The role emphasizes designing RWE studies, leveraging AI-driven approaches, and identifying data sources to enhance patient safety in medical devices.

Qualifications

• Master's degree in Epidemiology, Health Outcomes, Biostatistics, Data Science, or related field.
• 3–4 years of relevant epidemiologic research experience in academia, CRO, or industry.
• Strong knowledge of R, SQL, SAS.
• Working knowledge of applied epidemiologic methods.
• Experience with healthcare real-world data sources (claims, EHR, hospital billing).
• Excellent oral and written communication; capable of presenting to technical and lay audiences.

Responsabilités

• Design and conduct real-world evidence surveillance and safety studies for post-market activities.
• Write study protocols and reports; apply various analytical techniques to diverse databases.
• Collaborate with Medical Safety, Clinical Research, and Medical Affairs to plan research programs.
• Identify and evaluate new real-world data sources for safety monitoring and AI-driven approaches.
• Engage with academic institutions, health systems, registries and partners for data sourcing.

Connaissances

R

SQL

SAS

Epidemiology Methods

Data Analysis

Formation

Master's degree in Epidemiology

Ph.D. in a related field (preferred)

Description du poste

Epidemiologist Medical Device Epidemiology and Real-World Data Sciences

We are recruiting for an Epidemiologist for Medical Device Epidemiology and Real-World Data Sciences. This role is remote. Our Epi-RWDS organization is a leader in the medical device industry for using real-world evidence (RWE). We provide skills in using data sources (e.g. product complaints, registries, administrative healthcare claims, electronic health records, and regulatory safety databases) to answer research questions. These questions may center on post-market surveillance, safety, product development, value demonstration for payers, label extensions, robotic surgery insights, predictive analytics and artificial intelligence. All this is done to improve patient safety.

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