Principal Statistical Programmer FSP-RWE

Cytel • Columbia, SC • 4h ago

The Principal Real-World Evidence (RWE) Scientist will provide scientific and analytical leadership for real-world evidence generation using large healthcare data sources, including administrative claims and electronic medical records (EMR). This role supports the evaluation of real-world clinical and economic outcomes for products, with a strong focus on oncology. This role will lead the tactical planning, execution, and oversight of RWE studies, ensuring the timely delivery of high-quality, scientifically robust research outputs.

Support the design and execution of RWE studies or internal analytic projects using administrative claims and EMR data, including development of research protocols and input into statistical analysis plans (SAPs).

· Oversee end-to-end project execution in collaboration with external research vendors and/or internal analytics teams.

· Provide scientific guidance to ensure methodological rigor, data quality, and interpretability of study findings.

· Manage project timelines, milestones, and deliverables, ensuring adherence to agreed-upon schedules.

· Coordinate and facilitate study team communication, including preparation and dissemination of interim and final study results to key stakeholders.

· Stay current with evolving RWE methodologies, regulatory expectations, and industry best practices, applying relevant innovations to ongoing projects.

· Support recurring reports, ad hoc analyses, and regulatory or scientific dissemination activities as required.

· PhD in Epidemiology, Biostatistics, Health Outcomes Research, or a related field with 2+ years of relevant post-graduate research experience; or MS in Epidemiology or a related discipline with 4+ years of applied research experience.

· Minimum 2 years of hands-on experience analyzing healthcare claims and EMR databases (e.g., Flatiron or similar).

· Demonstrated experience managing RWE projects utilizing secondary data sources and/or chart review studies.

· Strong understanding of observational study design, bias mitigation, and real-world data limitations.

· Proven ability to manage multiple projects concurrently in a fast-paced environment including timeline management and budget tracking.

· Experience conducting RWE research in oncology is strongly preferred.

· Excellent collaboration, communication, and stakeholder-management skills.

· Ability to operate independently while working effectively within cross-functional and matrixed teams.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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