Senior Biostatistician

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.

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