Principal Biostatistician

Job Title:

Principal Biostatisticians

Toronto/Markham, Ontario, Canada on-site location, or remote anywhere in Canada.

• Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients, providing day‑to‑day technical and operational leadership to project teams.
• Provide statistical oversight on projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modelling, data handling, analysis, and reporting.
• Coach, mentor, develop, and provide technical review, advice, and expertise to less experienced Biostatisticians as well as Statistical Programmers.
• Provide statistical input in protocol design and development; participate in the writing of trial protocols and research proposals.
• Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically to drug development and commercialization at the study and drug compound/therapeutic area levels.
• Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan, and Data Management Plan.
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodology sections of Clinical Study Reports; perform peer review of SAPs and other technical documents written by others.
• Perform hands‑on statistical analysis and modelling, maintaining expertise in state‑of‑the‑art statistical methodology and regulatory requirements.
• Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate.
• Perform overall quality control review on statistical deliverables before release to clients.
• Review and confirm ADaM dataset specifications; perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
• Provide statistical consultation to medical and clinical trial personnel for the publication of trial results and participate in writing of abstracts, manuscripts, posters, and presentations.
• Ensure all study‑level and drug program‑level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
• Interact with regulatory agencies and support sponsor in new drug application, acting as a statistical liaison and ensuring documentation meets regulatory agency requirements (e.g., CDISC).
• Perform statistical and programming resource management, capacity analysis, benchmarking, and metrics. Participate in continuous improvement and maintenance of statistical and programming governing documents.
• Contribute to organization development and growth by participating in interview and evaluation process for professional applicants.

• A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience.
• Or a Master’s degree in the above fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance.

• Robust benefits package including medical, dental, vision coverage; life & AD&D insurance; short‑ and long‑term disability; tuition reimbursement; fitness reimbursement; employee assistance program (EAP); pension plan; generous paid time off and sick leave; opportunity to earn a performance‑based bonus.
• Estimated Salary Range: $150,000 - $200,000.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.