Director Real World Data Scientist (Billerica MA)
EMD Serono, Inc. · Billerica, MA · 3 days ago
Research$175k–$262k/yrFull-time
Key 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.
Minimum Qualifications
- PhD in statistics, biostatistics, epidemiology, applied mathematics, data science, or a related quantitative discipline.
- 8 or more 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.
Preferred Qualifications
- Recognized scientific thought leadership in RWE, statistics, or a related field.
- Track record of advancing or applying innovative methodologies in real-world settings.
- Experience integrating diverse data sources and evidence types.
- Proficiency in R, python, or other programming languages.
- Experience engaging with regulators or external scientific communities on methodological topics.