Principal Biostatistician

Everest Clinical Research; Markham; Hybrid; CAD 150,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life & AD&D insurance

Tuition reimbursement

Fitness reimbursement

Employee assistance program (EAP)

Pension plan

Generous paid time off and sick leave

Performance-based bonus

Job summary

Everest Clinical Research is seeking a committed Principal Biostatistician to manage clinical trial projects while providing statistical leadership. This role is based in Markham, Ontario, with remote work options available across Canada.

The ideal candidate will possess either a Ph.D. with 7 years of experience or a Master’s with 10 years, showcasing exceptional performance in statistical analysis and clinical development. A robust benefits package and a salary range of $150,000 - $200,000 are offered.

Qualifications

• At least 7 years of relevant experience with a Ph.D.; or 10 years with a Master’s.
• Exceptional ability and performance in the field.

Responsibilities

• Manage clinical trial programs/projects, providing technical leadership.
• Provide statistical oversight in drug development programs.
• Collaborate with teams on statistical input for trial protocols.
• Coach and mentor less experienced biostatisticians.

Education

Ph.D. in statistical science, mathematical analysis, or related field

Master’s degree in statistical science, mathematical analysis, or related field

Job description

We seek committed, skilled, customer‑focused individuals to join our team as Principal Biostatisticians. This role is based in Toronto/Markham, Ontario, Canada, with options to work remotely from any Canadian location in accordance with our Work from Home policy.

Key Accountabilities

• Work with the 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 supporting these programs/projects.
• Provide statistical oversight on projects in assigned drug development programs, ensuring sound statistical methods in study design, sample size estimation, statistical analysis planning, modeling, data handling, analysis, and reporting.
• Coach, mentor, develop, and provide technical review, advice, and expertise to less experienced biostatisticians and statistical programmers assigned to the program/projects.
• Provide statistical input in protocol design and development, and participate in the writing of trial protocols and research proposals.
• Serve as a primary biostatistician, collaborating 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, ongoing data review tables, listings, and figures, and Data Management Plan.
• Write Statistical Analysis Plans (SAPs), 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 modeling, maintaining expertise in state‑of‑the‑art statistical methodology and regulatory requirements.
• Validate core statistical tables, listings, and figures programmed by statistical programmers or biostatisticians; perform overall quality control review before release to clients.
• Review and confirm ADaM dataset specifications and perform quality control 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; participate in writing abstracts, manuscripts, posters, and presentations.
• Ensure all study‑level and drug program‑level statistical and programming activities comply with relevant regulatory requirements and applicable standards/conventions.
• Interact with regulatory agencies and support sponsor in new drug applications, including serving as a statistical liaison to ensure documentation, results, and datasets meet regulatory expectations (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 organizational development by participating in the interview and evaluation process for professional applicants.

Qualifications and Experience

• A Ph.D. in statistical science, mathematical analysis, or related field 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, demonstrating exceptional ability and performance.

Benefits & Compensation

We offer a 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), a pension plan, generous paid time off and sick leave, and an opportunity to earn a performance‑based bonus. Estimated salary range: $150,000 - $200,000.

Equal Opportunity Statement

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.