Senior Biostatistician

Job description

**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 based in Canada.** This role offers the opportunity to provide senior statistical expertise across clinical trials and research projects within a fast-growing, international clinical research environment. You will contribute across the full study lifecycle, from statistical planning and methodology through analysis, reporting, data quality, and publication support. The position combines hands-on statistical work with project leadership, quality oversight, and close collaboration across statistical programming, data management, and trial teams. You will help ensure that clinical research deliverables are accurate, compliant, efficient, and delivered on time. The role also provides exposure to advanced statistical methodologies, industry standards, and complex clinical datasets. You can work remotely from anywhere in Canada or from an on-site location in Toronto/Markham, Ontario, depending on the applicable work arrangement. ### Accountabilities: - Lead efforts to resolve day-to-day statistical and programming issues, helping maintain high-quality deliverables while improving the efficiency and productivity of statistical and programming operations. - Lead assigned clinical research projects by applying statistical expertise, programming knowledge, and project management skills to deliver high-quality work on schedule while supporting strong client relationships and repeat business. - Provide statistical expertise for the design, analysis, and reporting of clinical trials and research projects, ensuring appropriate methodologies are applied throughout the study lifecycle. - Contribute to statistical sections of study protocols, including sample size calculations, randomization specifications, and the generation of randomization codes, while ensuring methodological decisions are appropriately documented. - Develop Statistical Analysis Plans and address peer statistician review comments, as well as create and maintain statistical and programming quality control and quality assurance plans for assigned projects. - Support unblinded data management planning when required and contribute to the research and development of statistical methodologies, processes, and best practices. - Develop and review ADaM dataset specifications and provide input into SDTM specifications when needed, while performing quality control validation of analysis datasets and tables, listings, and figures. - Lead statistical dry runs and final runs by contributing to project and resource management, resolving statistical and programming questions, coordinating with data management, and following through on data issues. - Perform statistical analyses according to approved Statistical Analysis Plans, complete validation of core results, and address peer and quality control review comments and findings. - Support trial results reporting and dissemination activities, including meetings, clinical study reports, abstracts, manuscripts, presentations, and posters, while ensuring statistical results are accurate, complete, and appropriately interpreted. - Provide statistical input into Case Report Form design, database and variable structures, non-CRF data collection methods, Data Management Plans, and Data Validation Specifications. - Specify or program database quality acceptance checks, assess and communicate data quality issues and protocol deviations, and work with relevant teams through resolution and database lock preparation. - Complete required and project-specific training while complying with applicable policies, standard operating procedures, work instructions, and clinical trial sponsor requirements. - Maintain appropriate study documentation and archive project files according to applicable sponsor requirements, while actively pursuing professional development and maintaining current statistical and clinical research knowledge. ### Requirements - Ph.D. in statistical science, mathematical analysis, or a related field with at least two years of highly relevant experience, or a Master’s degree in a relevant discipline with at least four years of highly relevant experience and a demonstrated record of sustained performance. - Strong statistical expertise applicable to the design, analysis, and reporting of clinical trials and research projects, with the ability to translate statistical methodology into practical study deliverables. - Experience developing Statistical Analysis Plans, performing sample size calculations, supporting randomization, conducting statistical analyses, and interpreting clinical trial results. - Knowledge of clinical data standards and statistical programming processes, including experience with ADaM and SDTM dataset specifications, analysis datasets, and tables, listings, and figures. - Strong understanding of statistical quality control and validation processes, including the ability to review statistical outputs, investigate discrepancies, address QC findings, and maintain appropriate QA and QC documentation. - Experience working collaboratively across statistical programming, data management, trial management, and other clinical research functions, with the communication skills needed to resolve complex project issues. - Strong project management and organizational skills, with the ability to manage competing priorities, coordinate resources, meet deadlines, and maintain high standards of quality. - Excellent analytical and problem-solving capabilities, with a proactive approach to identifying data, statistical, operational, or methodological issues and driving them toward resolution. - Strong written and verbal communication skills, with the ability to explain statistical concepts clearly and contribute effectively to protocols, reports, Clinical Study Reports, publications, and stakeholder discussions. - Demonstrated commitment to professional development and the ability to remain current with relevant statistical methodologies, clinical research practices, industry standards, policies, and procedures. - Ability to work independently while contributing effectively to a collaborative, customer-focused, and internationally distributed clinical research environment. ### Benefits - Estimated salary range of **$110,000–$160,000 CAD**, with actual compensation based on relevant qualifications, experience, and role considerations. - Opportunity to earn a **performance-based bonus** in addition to base compensation. - Comprehensive **medical, dental, and vision coverage** to support employee health and well-being. - **Life and AD&D insurance** along with short-term and long-term disability coverage. - **Tuition reimbursement** and **fitness reimbursement** to support continued learning and personal well-being. - Access to an **Employee Assistance Program (EAP)** and resources supporting overall employee wellness. - **Pension plan** supporting long-term financial planning and retirement. - Generous **paid time off and sick leave**. - Flexible work arrangement with the opportunity to work **remotely from a home-based office anywhere in Canada** in accordance with the applicable work-from-home policy, or from an on-site location in Toronto/Markham, Ontario. - Opportunity to contribute to meaningful clinical research involving pharmaceuticals, biotechnology, and medical devices while working across complex statistical and data management projects. - Professional development opportunities within an international, collaborative clinical research environment. - Inclusive workplace committed to dignity, independence, integration, and equal opportunity, including accommodations for candidates with disabilities throughout the recruitment and selection process.