Senior Manager, Real-World Evidence Strategy in Epidemiology

Boston Scientific Corporation; Arden Hills (MN); Hybrid; USD 126,000 - 239,000; Full time

Job summary

Boston Scientific Corporation seeks a Senior Manager, Clinical Real-World Evidence Strategist in Epidemiology to lead enterprise RWE programs and translate clinical questions into robust observational studies. You will define endpoints, cohorts, and analyses while partnering with Clinical, Regulatory, and Biostatistics teams to ensure rigorous, credible evidence across the product lifecycle.

The role emphasizes collaboration with biostatistics and data science to apply rigorous epidemiologic

Qualifications

• Bachelor's or Advanced degree in Epidemiology, Clinical Research, Biostatistics, Public Health, Medicine, Health Services Research, Outcome Research, or related discipline preferred.
• Minimum of 7 years of experience in clinical research, epidemiology, biostatistics, outcomes research, or real‑world evidence, including 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.

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, 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.

Skills

Epidemiology

Observational research

Biostatistics

Scientific communication

Coding systems ICD

R

SAS

Python

SQL

Education

Epidemiology degree

Biostatistics degree

Public Health degree

Tools

R

SAS

Python

SQL

Job description

Boston Scientific Corporation seeks a Senior Manager, Clinical Real-World Evidence Strategist in Epidemiology to lead enterprise RWE programs and translate clinical questions into robust observational studies. You will define endpoints, cohorts, and analyses while partnering with Clinical, Regulatory, and Biostatistics teams to ensure rigorous, credible evidence across the product lifecycle.

The role emphasizes collaboration with biostatistics and data science to apply rigorous epidemiologic