Senior Manager, Clinical RWE Strategist, Epidemiology
Core
Lead strategic real-world evidence (RWE) programs and observational research to support regulatory, clinical, and commercial decision-making for medical devices.
Role type
Senior Manager, Clinical RWE Strategist (Epidemiology)
Builds
Enterprise-wide RWE strategies, observational study protocols, and evidence generation for product lifecycle management.
Domain
Medical Devices / Clinical Epidemiology / Real-World Evidence
Required skills
Clinical epidemiology, observational study design, biostatistical principles, protocol development, endpoint selection, bias and confounding assessment, causal inference, healthcare data validation, regulatory science, scientific writing
Preferred skills
PhD/MD/MPH in Epidemiology or related field, experience with claims/EHR/registry data, publication record
Technologies
Claims data, Electronic Health Records (EHR), Registries, Device-generated data
Responsibilities
Lead enterprise RWE initiatives and methodological expertise in study design; Collaborate with physicians and regulatory teams to transform clinical questions into rigorous RWE studies; Design observational studies using real-world data sources; Develop study concepts, protocols, and statistical analysis plans; Provide expertise on epidemiologic methods and study validity; Guide identification of clinical concepts and patient populations; Partner with biostatistics teams on analytical approaches; Drive enterprise strategies for leveraging RWD for business and research purposes; Represent the company in scientific and regulatory forums; Author scientific documents and regulatory submissions.