Work Flexibility: Hybrid
As a Program Manager, Real-World Evidence oversees and manages the design and execution of multiple RWE studies to support clinical evidence needs. Working with key stakeholders, the role will execute on key RWE deliverables, establishstandards and best practices for RWE study design and reporting, and support the integration of real-world data sources as an essential part of the clinical evidence generation strategy for Stryker’s product portfolio.
What You Will Do
1. 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
2. Manage planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical studies, leveraging collaborators and stakeholders
3. Lead the design and execution of RWE studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs, Regulatory, HEOR, and Commercial
4. Ensure scientific rigor and serve as a methodology expert for RWE generation; select and implement appropriate analytic methods aligned to research needs
5. 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
6. Ensure scientific rigor and serve as a methodology expert for real-world evidence generation; select and implement appropriate analytic methods aligned to research needs
7. 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
8. Conduct feasibility assessment of relevant data sources for specific devices and indications to ensure data is fit-for-purpose
9. Collaborate with academic institutions, health systems, registries and/or other health data partners to identifyadditionalreal-world data sources for medical device evidence generation.
10. Ensure quality and performance standards for RWE projects are realistic and attained, and studies are conducted in line with quality/compliance framework
11. Identifiesareas of improvement with RWE processes and procedures, develops and implements best practices, and works to improve efficiencies and effectiveness
12. Participate in cross-functional and cross-divisional initiatives regarding RWE
What you need
13. Degree needed/PHD preferred
14. 8+ years relevant experience in epidemiology, pharmacoepidemiology,and/or observationalresearch in academia, a contract research organization, or the medical device or pharmaceutical industry
15. Hands-on experience with healthcare real-world data (RWD) sets such as patient registries, electronic medical records, hospital billing data, and insurance claims databases
16. 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
17. A sophisticated understanding and ability to analyze and interpret quantitative data is required together with working knowledge of RWE/observational study design and methodology
Preferred Qualifications:
18. Strong knowledge of standard statistical software (e.g.,SAS, R, Stata) is preferred and demonstrated ability to collaborate closely with statistical programmers
19. Experience authoring study protocols, study reports, conference abstracts, and peer-reviewed publications using RWD preferred
20. Well-developed interpersonal skills and the ability to work well independently as well as with colleagues and customers
21. Strong organizational skills, with ability to effectively and efficiently handle multiple tasks simultaneously, with precision, and to adapt to changes in responsibilities and workloads
Travel Percentage: 10%