This position leads the design and execution of regulatory-grade and commercial RWE studies to support clinical evidence needs. Working with key stakeholders, the role will execute on key RWE deliverables and establish standards and best practices for RWE study design and reporting as an essential part of the clinical evidence generation strategy for Stryker’s product portfolio.
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 new 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, Stata) and/or demonstrated ability to collaborate closely with statistical programmers; understanding of advanced statistical methods utilized for RWD analysis (e.g., propensity score matching)
Excellent oral and written communication skills, experience authoring study protocols, study reports, and peer-reviewed publications using RWD preferred
Strong organizational skills, with ability to effectively and efficiently handle multiple tasks simultaneously, with precision, and to adapt to changes in responsibilities and workloads
Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic
Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA and GDPR guidelines, and other confidential information
Travel Percentage: 10%