Principal Data Strategist, Real-World Evidence (RWE)

Quick Facts

• Role: Principal Data Strategist, Real-World Evidence (RWE)

• Focus: Enterprise real-world data strategy and advanced analytics for regulatory-aligned evidence generation

Description

Lead enterprise RWD strategy and advanced analytics initiatives to support scalable, regulatory-aligned real-world evidence generation. Shape fit-for-purpose RWD strategies, evaluate and operationalize external data assets, and lead RWE study execution using EHRs, claims, registries, and linked healthcare data. Partner across Clinical, Medical Affairs, Regulatory, HEMA, IT, Biostatistics, Quality, and R&D to deliver immediate evidence priorities and long-term data capabilities.

Responsibilities

• Support enterprise RWD strategy development and long-term data planning aligned with evidence generation priorities.

• Evaluate and operationalize external data assets (EHR, claims, registries, emerging healthcare data sources).

• Lead vendor assessments, including quality, linkage feasibility, scalability, governance, and regulatory suitability.

• Partner cross-functionally to enable data acquisition, governance, integration, and scalable analytics infrastructure.

• Provide fit-for-purpose data selection guidance, feasibility assessments, and analytic approach recommendations.

• Lead RWE study protocol design, including cohort definitions, endpoints, and analytic plans.

• Collaborate with KOLs and stakeholders to ensure robust, clinically meaningful analytical outputs.

• Validate methodologies and results for transparency, reproducibility, and audit-readiness.

• Apply rigorous epidemiologic and statistical methods to address bias, confounding, and data limitations.

• Translate findings into reports and insights for evidence generation, value messaging, publications, regulatory submissions, and strategic decisions.

• Ensure alignment of study design and execution with regulatory and methodological guidance.

• Oversee feasibility assessments and optimize study design based on data availability.

• Execute end-to-end RWE studies from protocol development through analysis, interpretation, and dissemination.

• Develop advanced analytics solutions (predictive modeling, AI/ML, phenotyping, NLP).

• Design dashboards and visualizations to communicate insights and support decision-making.

• Establish best practices for data science, reproducible research, validation, and governance.

• Support publications, presentations, and regulatory-aligned scientific communications.

• Partner cross-functionally and mentor team members to expand organizational analytics and RWE capabilities.

Requirements

• Bachelor’s degree or advanced degree in data science, biostatistics, epidemiology, computer science, health informatics, or related field (or equivalent experience).

• 5+ years with a Bachelor’s degree, or 3+ years with a Master’s degree, in real-world evidence, healthcare analytics, data science, epidemiology, or related disciplines.

• Proven experience with real-world healthcare data (EHR, claims, registries, linked datasets).

• Expertise in observational research methods, epidemiology, causal inference, and advanced statistical or machine learning methods.

• Proficiency in Python, R, SQL, and modern analytics environments.

• Experience evaluating external healthcare data assets and working with vendors/strategic data partnerships.

• Strong communication and stakeholder management across technical and business audiences.