Senior Director, Real-World Data Science

EMD Serono, Inc.; Billerica (MA); On-site; USD 174,600 - 262,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

EMD Electronics is seeking a Director of Real‑World Evidence to lead methodological strategy and credible analyses informing high‑impact development and regulatory decisions. This role blends advanced statistical rigor with scientific judgment and cross‑functional leadership.

You will shape evidence generation plans, evaluate study designs, and translate complex analyses into actionable insights for disease characterization, endpoint feasibility, and external control design across programs.

Qualifications

• PhD in statistics, biostatistics, epidemiology, applied mathematics, data science, or related quantitative discipline.
• 8+ years of experience in real‑world evidence, statistics, epidemiology, or related fields.
• Deep expertise in statistical methods, causal inference, and analysis of complex healthcare data.
• Strong understanding of real‑world data, data‑generating processes, and data limitations.
• Experience supporting regulatory and development decisions with high‑quality evidence.
• Demonstrated ability to influence cross‑functional teams and shape methodological direction.
• Excellent communication skills and strong scientific leadership presence.

Responsibilities

• Define key scientific questions underpinning evidence strategies.
• Provide leadership on RWE approaches supporting development and regulatory decisions.
• Serve as a recognized scientific authority on complex methodological topics.
• Identify methodological gaps, risks, and opportunities, and define pragmatic forward paths.
• Critically evaluate study designs, analytical strategies, and data sources.
• Apply deep expertise in statistical theory, bias, confounding, causal inference, and quantitative modeling.
• Assess whether methodological choices are fit‑for‑purpose, transparent, and scientifically defensible.
• Guide complex methodological decisions involving multiple sources of evidence and competing analytical options.
• Translate complex analysis into high‑impact, decision‑relevant insights.
• Shape evidence used to inform critical questions such as disease characterization, comparator strategy, endpoint feasibility, external control design, and patient population definition.
• Influence how evidence is generated and used in high‑stakes decisions across programs.
• Evaluate emerging methodologies, technologies, and data paradigms for relevance and impact.
• Evaluate and guide how real‑world data sources are selected, structured, and interpreted to support complex evidence needs.
• Apply deep understanding of data‑generating processes and data limitations to inform methodological choices.
• Shape how data is made accessible, interpretable, and usable for evidence generation across teams.
• Provide scientific input into data pipelines, transformations, and analytical workflows to ensure they align with study needs and methodological rigor.
• Partner with data science and engineering functions to ensure data infrastructure supports high‑quality, scalable, and reproducible analysis.
• Integrate innovations where they meaningfully improve rigor, efficiency, or interpretability.
• Partner across clinical development, biostatistics, regulatory, medical, HEOR, and data science.
• Act as a bridge across disciplines, aligning scientific perspectives and decision needs.
• Influence without authority in a complex matrix environment.
• Engage externally to support scientific credibility and methodological advancement.
• Contribute to methodological discussions with regulators, collaborators, or scientific communities where appropriate.
• Support publications, presentations, or collaborations aligned with strategic priorities.

Skills

Statistical methods

Causal inference

Communication

Leadership

Regulatory support

Education

PhD in statistics/biostatistics/epidemiology

Tools

R

Python

Job description

EMD Electronics is seeking a Director of Real‑World Evidence to lead methodological strategy and credible analyses informing high‑impact development and regulatory decisions. This role blends advanced statistical rigor with scientific judgment and cross‑functional leadership.

You will shape evidence generation plans, evaluate study designs, and translate complex analyses into actionable insights for disease characterization, endpoint feasibility, and external control design across programs.