- Lead design and execution of RWE studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs, and Clinical Data Science.
- Author and/or oversee development of study protocols, reports, conference abstracts, and peer-reviewed publications using RWD and collaborate cross-functionally to integrate RWD into global publication strategies
- Ensure scientific rigor and serve as a methodology expert for real-world evidence generation; select and implement appropriate analytic methods aligned to research needs
- Collaborate closely with data management and biostatistics functions to ensure data quality and deliver robust data analyses utilizing scientifically valid and accepted methodology for RWD
- Conduct feasibility assessment of relevant data sources for specific devices and indications to ensure data is fit-for-purpose
- Identify and evaluate recent RWD sources
- Ensure quality and performance standards for RWE projects are realistic and attained, and studies are conducted in line with quality/compliance framework
- Identifies areas of improvement with RWE processes and procedures, develops and implements best practices, and works to improve efficiencies and effectiveness. Participate in cross-functional and cross-divisional initiatives regarding RWE
What you need:
- 3-6 years relevant experience in epidemiology and/or observational research in academia, a contract research organization, and/or the medical device or pharmaceutical industry
- Hands-on experience with real-world data (RWD) sets such as patient registries, electronic medical records, hospital billing data, and insurance claims databases and familiarity with relevant medical coding vocabularies (e.g., ICD, CPT, HCPCS, LOINC)
- A sophisticated understanding and ability to analyze and interpret quantitative data is required together with working knowledge of RWE/observational study design and methodology
- Experience using standard statistical software (e.g., SAS, R, Sta