Senior Manager, Clinical RWE Strategist, Epidemiology
About The Position
The Senior Manager, Clinical Real-World Evidence (RWE) Strategist, Epidemiology is a scientific and methodological expert who leads the strategic use of real-world data (RWD) and evidence generation across Boston Scientific. The role applies clinical epidemiology and observational research expertise to translate clinical and business questions into rigorous RWE programs, working with stakeholders across Clinical, Regulatory, R&D, Medical Affairs, Marketing, HEMA, HEOR, and the divisions. It involves working with physicians, clinical scientists, biostatisticians, and regulatory professionals to design and execute observational studies using claims, electronic health records, registries, device-generated data, and other RWD sources. The position develops fit-for-purpose evidence strategies throughout the product lifecycle, with emphasis on scientifically rigorous protocols, clinically meaningful endpoints and target populations, assessment of bias and confounding, and study designs that support regulatory, clinical, reimbursement, and commercial decisions. The role contributes to establishing RWE as a core scientific capability at Boston Scientific, supporting device development, post-market evidence generation, indication expansions, labeling strategies, quality initiatives, and market differentiation. The position may be based in Marlborough, Massachusetts, or Arden Hills, Minnesota, and follows a hybrid work model requiring at least three days per week in a local office. Sponsorship and relocation assistance are not available for this position.
Requirements
- Bachelor’s or advanced degree in Epidemiology, Clinical Research, Biostatistics, Public Health, Medicine, Health Services Research, Outcomes Research, or a related discipline; the posting describes the degree as preferred.
- At least 7 years of experience in clinical research, epidemiology, biostatistics, outcomes research, or RWE, including substantial experience designing and conducting observational studies.
- Strong expertise in clinical epidemiology and observational research methods, including cohort studies, comparative effectiveness research, safety studies, pragmatic research, and causal inference methodologies.
- Experience developing study protocols, analysis plans, evidence-generation strategies, and publication plans with clinical stakeholders and biostatisticians.
- Ability to engage physicians, researchers, and clinical stakeholders in study-design discussions and translate clinical questions into executable RWE research programs.
- Deep understanding of claims, EHR, registry, and linked clinical data assets, including their strengths, limitations, and appropriate applications.
- Knowledge of confounding, selection bias, information bias, missing data, propensity score methods, sensitivity analyses, and study validity.
- Familiarity with ICD, CPT, HCPCS, SNOMED, and LOINC medical coding systems.
- Programming skills to retrieve relevant data from RWD sources and independently conduct feasibility and fit-for-purpose assessments.
- Strong scientific communication skills, including explaining complex epidemiologic and statistical concepts to multidisciplinary audiences.
Nice To Haves
- Experience supporting regulatory-grade RWE programs, including label expansions, post-market commitments, and evidence submissions to health authorities.
- Experience in the medical device industry and familiarity with device-specific RWE challenges and regulatory considerations.
- A publication record in peer-reviewed journals involving epidemiology, outcomes research, RWE, or clinical research.
- Familiarity with FDA, EMA, and IMDRF guidance and evolving global guidance on RWE in regulatory decision-making.
- Working knowledge of R, SAS, Python, and SQL sufficient to conduct studies independently and collaborate effectively with biostatisticians and data scientists.
- Experience collaborating with academic investigators, healthcare systems, registries, and external research partners.
Responsibilities
- Serve as the clinical epidemiology and observational research lead for enterprise RWE initiatives, providing expertise in study design, protocol development, endpoint selection, cohort definition, and interpretation of findings.
- Collaborate with physicians and Clinical Affairs, Medical Affairs, Regulatory Affairs, and Biostatistics to turn clinical questions into rigorous, fit-for-purpose RWE studies.
- Lead the design of observational studies using claims, electronic health records, registries, device-generated data, and other RWD sources, including cohort, comparative effectiveness, natural history, safety, and external control arm studies.
- Develop and review study concepts, protocols, statistical analysis plans, and publication strategies, ensuring methodological rigor and alignment with scientific and regulatory expectations.
- Provide expertise in epidemiologic methods, bias assessment, confounding control, missing data, causal inference, and study validity.
- Guide identification and validation of clinical concepts, patient populations, phenotypes, outcomes, and covariates using structured and unstructured healthcare data.
- Partner with biostatistics and data science teams to ensure appropriate methodologies, analytical approaches, and interpretation of study findings.
- Drive enterprise-wide strategies for leveraging RWD for clinical, regulatory, marketing, business development, and research purposes, including value messaging, publications, label expansions, and post-market surveillance.
- Serve as an RWE and observational research subject matter expert for internal stakeholders and external partners.
- Represent Boston Scientific in scientific, regulatory, and professional forums, including academic collaborations, health-system partnerships, conferences, and industry working groups.
- Author and review scientific documents, including protocols, statistical analysis plans, study reports, conference abstracts, manuscripts, regulatory submissions, and peer-reviewed publications.
Benefits
- Core and optional employee benefits are offered; specific benefits are not detailed in the posting.
- Compensation for exempt, non-sales roles may include an annual bonus target and long-term incentives, subject to plan eligibility and other requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
