• Provide strategic insight to evidence required by cross-functional project teams focused on market access, or sustaining product portfolios. The position will require global clinical insight into launch strategies across multiple regions  
• Manage planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical studies, leveraging collaborators and stakeholders 
• Lead the design and execution of RWE studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs, Regulatory, HEOR, and Commercial 
• Ensure scientific rigor and serve as a methodology expert for RWE generation; select and implement appropriate analytic methods aligned to research needs
• Author and/or oversee development of study protocols, reports, 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 
• Collaborate with academic institutions, health systems, registries and/or other health data partners to identify additional real-world data sources for medical device evidence generation. 
• 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

• Degree needed/PHD preferred
• 8+ years relevant experience in epidemiology, pharmacoepidemiology, and/or observational research in academia, a contract research organization, or the medical device or pharmaceutical industry 
• Hands-on experience with healthcare real-world data (RWD) sets such as patient registries, electronic medical records, hospital billing data, and insurance claims databases 
• A basic understanding of the clinical evidence needs in the global regulatory environment for clinical investigation, clinical evaluation, post-market clinical follow-up, and product ratings of medical devices and technologies that can be addressed using RWD
• A sophisticated understanding and ability to analyze and interpret quantitative data is required together with working knowledge of RWE/observational study design and methodology 

• Strong knowledge of standard statistical software (e.g., SAS, R, Stata) is preferred and demonstrated ability to collaborate closely with statistical programmers
• Experience authoring study protocols, study reports, conference abstracts, and peer-reviewed publications using RWD preferred 
• Well-developed interpersonal skills and the ability to work well independently as well as with colleagues and customers 
• Strong organizational skills, with ability to effectively and efficiently handle multiple tasks simultaneously, with precision, and to adapt to changes in responsibilities and workloads