Biostatistician

Principal Biostatistician – Early Phase (PK) 🧬

CAD $240,000 base💰

Fully remote - Canada

Influence early-phase clinical strategy and PK-driven decision making across an innovative development portfolio 🎯

About

Join a leading global provider within the biotech/pharma space, supporting an innovative clinical development portfolio focused on advancing therapies that address significant unmet medical needs.

This role sits within early clinical development, with a strong emphasis on healthy volunteer studies and PK/PD endpoints. The environment is scientifically rigorous, collaborative, and fast-paced, with meaningful upcoming development milestones.

Why This Role Matters

Early-phase studies set the trajectory for an entire program. In this role, you will provide senior-level statistical expertise to ensure robust design, high-quality analysis, and clear interpretation of PK data that directly informs downstream clinical and regulatory strategy.

The team is seeking someone with genuine hands-on PK experience who enjoys owning their work while collaborating closely with Clinical Pharmacology, Clinical Development, and Data Management.

What You Will Do

• Provide statistical leadership for early-phase clinical studies with PK/PD endpoints
• Author statistical sections of protocols, including sample size calculations
• Develop and review SAPs, randomization specifications, datasets, and TLFs
• Perform and validate analyses using SAS (R a plus)
• Contribute to clinical study reports and regulatory documentation
• Partner cross-functionally to ensure aligned timelines and high-quality deliverables
• Support exploratory and IND-enabling analyses where required

What You Bring

• PhD in Statistics/Biostatistics with 3+ years of industry experience, or MS with 5+ years
• 2+ years of hands-on experience analyzing non-compartmental PK endpoints in industry
• Strong understanding of ICH GCP and regulatory expectations for clinical pharmacology studies
• Experience working with CDISC standards (SDTM, ADaM, CDASH)
• Proficiency in SAS for independent analysis and validation
• Ability to independently manage projects and make sound statistical decisions
• Strong communication skills and experience collaborating with cross-functional teams

Preferred: Exposure to statistical modeling, simulation methods, or PD/biomarker analyses.

Why It’s Special

• Fully remote across Canada
• High-impact early development work
• Strong balance of autonomy and collaboration
• Opportunity suited to someone senior yet still technically hands-on
• Stable environment with long-term visibility