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2 weeks ago
FSP Principal Biostatistician – Early Phase Clinical Development (PK) | Home-based | Canada | Permanent |
We are working with a leading global CRO who have an opportunity within their FSP team for a Senior or Principal Biostatistician to provide statistical support for early-phase drug development programs, focusing on healthy volunteer studies with PK and PD endpoints.
Collaborate with multidisciplinary teams to define project timelines and deliverables.
Author and review statistical sections of protocols, SAPs, datasets, and TLF specifications.
Review eCRFs and other data management documentation.
Conduct statistical analyses and validate key data derivations using SAS and/or R.
Monitor internal and CRO activities to ensure timelines, quality, and resource availability.
Collaborate with Clinical Development, Data Management, and Clinical Pharmacology/PK teams.
Contribute to clinical study reports and regulatory documents (e.g., Support exploratory analyses and, where applicable, IND activities.
D. in Statistics, Biostatistics, or related field with 3+ years of experience, or M.Minimum 2 years of experience with non-compartmental PK analysis.
Knowledge of ICH GCP, regulatory guidance, and CDISC standards (SDTM, ADaM, CDASH).
Strong SAS skills and ability to manage multiple projects independently.
Familiarity with statistical modeling, simulations, and PD/biomarker analyses.
Must have Canadian passport or permanent resident status to apply.
Home-based remote working opportunities.
Research opportunities that match your unique skillset.
Promising career trajectory with technical training and tailored development plan.
Job stability - long-term engagements and re-deployment opportunities.
Good work-life balance and flexible schedules.
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