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.

Key Responsibilities

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.

Requirements

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.

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