Senior Analyst- Epidemiologist, Real-World Evidence (RWE)

• 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