Principal Biostatistician
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Biostatistician based in Canada.
This senior-level role offers the opportunity to shape the statistical strategy behind global clinical development programs spanning pharmaceuticals, biotechnology, and medical devices. You will act as a scientific leader across multiple trials, ensuring the integrity and rigor of statistical design, analysis, and reporting throughout the drug development lifecycle. The position combines hands-on advanced biostatistical work with strategic oversight and cross-functional collaboration in a fast-paced, regulated environment. You will contribute directly to study design, regulatory submissions, and clinical evidence generation that supports new therapies reaching patients. Acting as both technical expert and mentor, you will guide junior statisticians and programmers while driving methodological excellence. This role is ideal for someone passionate about applying advanced statistics to meaningful, real-world healthcare innovation.
Accountabilities:
In this role, you will provide statistical leadership across clinical trial programs, ensuring scientific rigor, regulatory compliance, and high-quality deliverables throughout the development lifecycle.
- Lead statistical strategy and provide day-to-day technical oversight for multiple clinical trial projects across different therapeutic areas
- Design and review statistical methodologies including study design, sample size calculations, analysis plans, and modeling approaches
- Author and review key study documents such as Statistical Analysis Plans (SAPs), study protocols, and clinical study report sections
- Provide statistical input into clinical data management deliverables including eCRFs, validation plans, and data review specifications
- Perform hands-on statistical analysis, validation of outputs, and quality control of tables, listings, figures, and ADaM datasets
- Collaborate with cross-functional teams and provide statistical consulting for publications, abstracts, posters, and manuscripts
- Serve as a statistical liaison for regulatory interactions and support submissions for new drug applications
- Mentor and guide junior biostatisticians and statistical programmers while contributing to resource planning and process improvement initiatives
- Ph.D. in Statistics, Biostatistics, Mathematics, or a related field with at least 7 years of relevant experience, or a Master’s degree with 10+ years of experience in clinical biostatistics
- Extensive experience working in clinical trials within a Contract Research Organization (CRO) or pharmaceutical/biotech environment
- Strong expertise in statistical methodologies including study design, modeling, analysis planning, and regulatory submission support
- Proficiency with clinical data standards such as CDISC, ADaM, and related regulatory requirements
- Strong programming and analytical skills (e.g., SAS or similar statistical software)
- Proven ability to lead cross-functional teams and mentor junior staff in a collaborative environment
- Excellent communication skills with the ability to interact with internal stakeholders and regulatory agencies
- Strong attention to detail, organizational skills, and ability to manage multiple complex projects simultaneously
- Preferred experience in publications, scientific writing, and regulatory submissions
- Competitive compensation package with estimated salary range of $150,000 – $200,000
- Comprehensive health benefits including medical, dental, and vision coverage
- Life insurance, AD&D coverage, and short- and long-term disability plans
- Retirement savings plan (pension) to support long-term financial security
- Generous paid time off, sick leave, and work-life balance support
- Tuition reimbursement and continuous learning opportunities
- Fitness reimbursement and employee assistance program (EAP) for wellbeing support
- Performance-based bonus eligibility
- Flexible work arrangements including remote options across Canada.
Requirements:
The ideal candidate brings deep expertise in biostatistics within clinical research, along with strong leadership capabilities and a solid understanding of regulatory standards.