Biostatisticien principal/Principal Biostatistician

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Biostatisticien principal / Principal Biostatistician in Canada.

In this role, you will lead biostatistical efforts across multiple clinical trials, from Phase 1 to Phase 4, providing statistical expertise in protocol development, data analysis, and reporting. You will oversee statistical programming teams, ensure high-quality deliverables, and guide the design and analysis of studies with regulatory compliance in mind. The role involves collaborating closely with cross-functional teams, mentoring colleagues, and driving internal initiatives to enhance efficiency and quality. You will contribute to regulatory submissions, interim analyses, and complex data interpretations while ensuring consistency in methodologies across trials. This position is ideal for someone passionate about applying biostatistics to advance clinical research and making a meaningful impact on healthcare development.

Accountabilities:

· Serve as Lead Biostatistician on multiple Phase 1–4 clinical trials, acting as the primary statistical point of contact.

· Develop, review, and implement Statistical Analysis Plans (SAPs), TLF shells, and associated documentation.

· Provide biostatistical oversight for programs of clinical trials, ensuring consistency in methodologies and regulatory compliance.

· Support and manage teams of Statistical Programmers performing analyses of clinical trial data.

· Review protocol statistical sections, Risk-Based Monitoring Plans, and Data Management documents to ensure scientific rigor and quality.

· Act as Unblinded Biostatistician for Randomization Lists and Interim Analyses, and support Independent Data Monitoring Committees.

· Lead initiatives to improve efficiency, quality, and training within the biostatistics function.

· Advise on innovative study designs, regulatory submissions, and data interpretation for decision-making.

· Master's or PhD in Statistics, Biostatistics, or a related field with applied biostatistics training relevant to clinical trials.

· Minimum of 10 years of experience in clinical trials within pharmaceutical, biotechnology, or CRO environments, including at least 7 years as Lead Biostatistician.

· Strong knowledge of ICH guidelines (E6(R2), E9, E9(R1)), Health Canada, and FDA regulations.

· Extensive experience with CDISC standards, clinical trial data, SAPs, and TLF shells.

· Advanced proficiency in SAS for statistical analysis of clinical trial data.

· Strong organizational, project management, and time management skills with attention to detail.

· Ability to work independently and collaboratively in a fast-paced environment, managing multiple competing priorities.

· Excellent verbal and written communication skills in English; French is an asset.

· Experience leading internal initiatives or mentoring colleagues is an advantage.

· Competitive full-time permanent position with flexible work schedule.

· Comprehensive benefits package including medical, dental, vision, RRSP, and personal days.

· Paid vacation and access to virtual medical services.

· Opportunities for ongoing learning, professional development, and career advancement.

· Collaborative and innovative work environment with global exposure.

· Support for commuting costs and participation in social activities.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
It compares your profile to the job's core requirements and past success factors to determine your match score.
Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest

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