Job Details
FSP Principal Biostatistician - RWE
6003
Posted: 28/10/2025
- £Competitive
- Home Based - Canada , Canada
- Permanent
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.
What you will be doing:
What you will need:
What’s in it for you:
What to do next?
If this opportunity is of interest, please apply now with your CV as we are looking to arrange interviews soon.
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.
What you will be doing:
- 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.
- Provide strategic recommendations to support drug development, market access, and lifecycle management.
- 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.
What you will need:
- 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.
- Understanding of ICH GCP, ICH E9, and CDISC standards (SDTM, ADaM, CDASH).
- Excellent communication, problem-solving, and collaboration skills.
What’s in it for you:
- 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.
- Engaging, fast-paced environment with good work-life balance.
What to do next?
If this opportunity is of interest, please apply now with your CV as we are looking to arrange interviews soon.
Jo Fornaciari
Principal Consultant | Biometrics
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