Principal Biostatistician RWE

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Principal Biostatistician – RWE (FSP) | Canada | Fully Remote | Permanent

We’ve partnered with a leading global CRO who are expanding their FSP team with a Principal Biostatistician to drive real‑world evidence (RWE) strategy. In this role, you’ll work with cutting‑edge real‑world datasets to support regulatory, clinical, and commercial decision‑making for innovative therapies.

• Source, access, and manage diverse real‑world datasets (EHRs, claims, registries, etc.).
• Develop and optimize data pipelines and ensure data quality/compliance.
• Lead statistical analyses using advanced methodologies (propensity scores, causal inference, survival models, ML).
• Deliver comparative effectiveness, outcomes, and pharmacoeconomic insights.
• Author protocols, SAPs, technical reports, and regulatory‑aligned documentation.
• Prepare high‑impact reports, visualizations, and publications.
• Provide strategic recommendations across drug development and market access.
• Champion data integrity, reproducibility, and validation best practices.

• PhD in Biostatistics/Statistics or MSc with 5+ years industry experience.
• Hands‑on experience with RWE/RWD studies.
• Strong programming in R, Python, or SAS; SQL and visualization skills (Tableau, Power BI, Shiny).
• Familiarity with FDA/EMA RWE guidance, ISPOR/ISPE standards, and CDISC.
• Excellent communication and cross‑functional collaboration skills.

Interested?

Apply now with your CV — interviews are being scheduled shortly.