This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Biostatistician Consultant based in Canada.
This role sits at the intersection of advanced statistical science and clinical innovation, supporting the development of therapies that directly impact patient outcomes. The Senior Biostatistician Consultant will lead the design and execution of statistical analyses across clinical trial programs, ensuring scientific rigor and regulatory compliance. Working within a cross-functional and highly collaborative environment, the role contributes to study design, protocol development, and statistical analysis planning. The position requires strong technical expertise in biostatistics as well as the ability to translate complex data into actionable insights for clinical and regulatory stakeholders. It offers exposure to diverse biotech, pharmaceutical, and medical device projects across the full product lifecycle. The consultant will also play a key role in mentoring junior statisticians and improving internal statistical processes. This is a high-impact role suited to professionals who thrive in fast-paced, regulated environments.
Accountabilities:
- Lead statistical activities for clinical trials, including study design, statistical analysis plan (SAP) development, and execution of analyses.
- Provide statistical expertise to cross-functional teams such as clinical operations, regulatory affairs, data management, and medical writing.
- Ensure accuracy and quality of statistical deliverables, including tables, listings, figures, and clinical study reports.
- Contribute to study protocols and CRF design to ensure appropriate statistical methodology is embedded from the outset.
- Develop, validate, and maintain SAS and/or R programming for clinical data analysis in compliance with SOPs and regulatory standards.
- Support process improvement initiatives to enhance statistical efficiency, consistency, and quality across projects.
- Provide mentorship and guidance to junior statisticians.
Requirements:
- PhD or Master’s degree in Biostatistics or a related quantitative field.
- 3+ years of experience in biostatistics, ideally within clinical trials or consulting/outsourcing environments.
- Strong expertise in clinical trial design, sample size calculation, and statistical analysis.
- Proficiency in SAS and/or R programming.
- Solid knowledge of CDISC standards (SDTM, ADaM).
- Understanding of regulatory guidelines governing clinical trial analysis and reporting.
- Strong communication and collaboration skills in cross-functional environments.
- Ability to manage multiple projects and priorities in a fast-paced setting.
Benefits:
- Competitive compensation aligned with experience
- Flexible work arrangements (remote/hybrid depending on project needs)
- Exposure to global clinical research programs across leading life sciences organizations
- Opportunity to work on innovative drug and medical device development projects
- Collaborative and expert-driven environment
- Continuous learning, mentorship, and career development opportunities
- Inclusive and diverse workplace culture