Project Statistician

2 weeks ago

Canada Warman O'Brien Full time

FSP Principal Biostatistician – RWE | Canada | Home Based | Permanent | FSP |
We are working with a leading global CRO who have an opportunity within their FSP team for a Principal Biostatistician to lead statistical support for novel clinical research using real-world data (RWD). This fully remote position offers the opportunity to work with cutting-edge datasets and contribute to impactful regulatory and commercial decisions.

Identify and access diverse RWD sources (EHRs, claims, registries, and other datasets).
Collaborate with data vendors and healthcare organizations to ensure quality, compliance, and accessibility.
Develop robust data pipelines to support study objectives.
Design and execute statistical analyses to generate real-world evidence (RWE).
Apply advanced methods including propensity score matching, survival analysis, regression modeling, and machine learning.
Conduct comparative effectiveness research, health outcomes, and pharmacoeconomic studies.
Collaborate with cross-functional teams to design RWE studies (retrospective cohorts, case-control studies, pragmatic trials).
Contribute to study protocols, SAPs, and technical reports aligned with regulatory standards (FDA, EMA).
Prepare reports, manuscripts, and presentations summarizing RWE findings for internal, regulatory, and publication purposes.
Develop automated reporting tools and data visualizations for diverse audiences.
Ensure compliance with regulatory guidelines (FDA 21st Century Cures Act, EMA RWE framework) and industry standards (ISPOR, ISPE).
Implement best practices for data integrity, reproducibility, and validation of statistical outputs.

PhD in Statistics, Biostatistics, or related field with 5+ years industry experience, or MS with 7+ years.
Proven expertise in RWD/RWE studies and experience with EHRs, claims, registries, or other datasets.
Strong programming skills in R, Python, or SAS; experience with SQL and data visualization tools (Tableau, Power BI, R Shiny).
Familiarity with version control systems (e.g., Git) and reproducible research practices.
Experience designing studies, developing protocols, SAPs, and supporting regulatory submissions.
Knowledge of statistical methodologies for RWD, including propensity scores, longitudinal analysis, and causal inference.
Fully remote with flexible scheduling.
Collaborative, high-performing statistical and research teams.
Opportunities for career growth, technical training, and impactful research.
Focus on advancing new therapies rather than administrative burdens.

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