Arden Hills Senior Manager, Clinical RWE Strategist, Epidemiology MN 55112

Job description

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. 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 (RWD) and evidence generation across Boston Scientific. This individual serves as a clinical epidemiology and observational research expert, 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. This role requires deep expertise in clinical epidemiology, study design, and biostatistical principles to support the development of fit-for-purpose evidence strategies across the product lifecycle. The successful candidate will work closely with physicians, clinical scientists, biostatisticians, and regulatory professionals to design and execute observational studies using claims, electronic health records, registries, and other real-world data sources.Particular emphasis will be placed on developing scientifically rigorous study protocols, defining clinically meaningful endpoints and target populations, evaluating potential sources of bias and confounding, and ensuring that study designs generate credible evidence to support regulatory, clinical, reimbursement, and commercial decision-making. The incumbent will contribute to establishing RWE as a core scientific capability of Boston Scientific, supporting device development, post-market evidence generation, indication expansions, labeling strategies, quality initiatives, and market differentiation. Work model, sponsorship, relocation: This position may be based in Marlborough, Massachusetts, or Arden Hills, Minnesota. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time. Your responsibilities will include: 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, Clinical Affairs, Medical Affairs, Regulatory Affairs, and Biostatistics to transform clinical questions into scientifically rigorous and fit-for-purpose RWE research studies. Lead the design of observational studies using claims, electronic health records, registries, device-generated data, and other real-world data sources, including cohort studies, comparative effectiveness studies, natural history studies, safety studies, and external control arms. Develop and review study concepts, protocols, statistical analysis plans, and publication strategies while ensuring methodological rigor and alignment with scientific and regulatory expectations. Provide expertise on epidemiologic methods, bias assessment, confounding control, missing data, causal inference, and study validity to support high-quality evidence generation. Guide the identification and validation of clinical concepts, patient populations, phenotypes, outcomes, and covariates using structured and unstructured healthcare data. Partner closely with biostatistics and data science teams to ensure appropriate study methodologies, analytical approaches, and interpretation of study findings. Drive the development and execution of 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. Required qualifications: Bachelor's or Advanced degree (PhD, DrPH, ScD, MD /DO , MPH, MS, or equivalent) in Epidemiology, Clinical Research, Biostatistics, Public Health, Medicine, Health Services Research, Outcome Research, or a related discipline preferred. Minimum of 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. Proven ability to engage physicians, researchers, and clinical stakeholders in study design discussions and translate clinical questions into executable RWE research programs. Deep understanding of clinical data assets including claims, EHR, registries, and linked datasets, along with their strengths, limitations, and appropriate applications. Knowledge of epidemiologic concepts including 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 to conduct feasibility and fit-for-purpose assessment independently. Strong scientific communication skills, including the ability to explain complex epidemiologic and statistical concepts to multidisciplinary audiences. Preferred qualifications: Experience supporting regulatory-grade RWE programs, including label expansions, post-market commitments, and evidence submissions to health authorities. Experience working in the medical device industry and familiarity with device-specific RWE challenges and regulatory considerations. Demonstrated 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 regarding the use of RWE in regulatory decision-making. Working knowledge of statistical software and analytical tools (R, SAS, Python, 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 . Requisition ID: 637299 Minimum Salary: $ 125800 Maximum Salary: $ 239000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual l