Senior Manager, Clinical RWE Strategist, Epidemiology

Boston Scientific•Marlborough, MA

11d•Hybrid

About The Position

The Senior Manager, Clinical Real-World Evidence (RWE) Strategist, Epidemiology serves as a scientific and methodological expert, leading the strategic use of real-world data and evidence generation across Boston Scientific. The role provides clinical epidemiology and observational research expertise, partnering with Clinical, Regulatory, R&D, Medical Affairs, Marketing, HEMA, HEOR, and divisional stakeholders to translate important clinical and business questions into scientifically rigorous real-world evidence programs. It requires deep expertise in clinical epidemiology, study design, and biostatistical principles to support fit-for-purpose evidence strategies across the product lifecycle. The successful candidate works 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 real-world data sources. Particular emphasis is placed on developing rigorous protocols, defining clinically meaningful endpoints and target populations, evaluating sources of bias and confounding, and ensuring studies generate credible evidence for regulatory, clinical, reimbursement, and commercial decision-making. 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 model requiring at least three days per week in a local office. Visa sponsorship and relocation assistance are not available.

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 lists advanced degrees as preferred.
At least 7 years of experience in clinical research, epidemiology, biostatistics, outcomes research, or real-world evidence, 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.
Demonstrated experience developing study protocols, analysis plans, evidence-generation strategies, and publication plans in collaboration 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 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 medical coding systems including ICD, CPT, HCPCS, SNOMED, and LOINC.
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, real-world evidence, or clinical research.
Familiarity with FDA, EMA, IMDRF, and evolving global guidance on use of RWE in regulatory decision-making.
Working knowledge of R, SAS, Python, and SQL sufficient to conduct studies independently and collaborate 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 methodological 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 scientifically rigorous, fit-for-purpose RWE studies.
Lead observational study design using claims, electronic health records, registries, device-generated data, and other real-world data 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 on study methodologies, analytical approaches, and interpretation of 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 a scientific and methodological subject matter expert on RWE and observational research 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.