Principal Biostatistician

Principal Biostatistician – Everest Clinical Research

Everest Clinical Research ("Everest") is a full‑service contract research organization (CRO) that offers expertise‑based clinical research services to global pharmaceutical, biotechnology, and medical device industries. Headquartered in Markham, Ontario, we also operate sites in Bridgewater, New Jersey;
Shanghai; and Taipei. Everest is recognized for high‑quality deliverables, superior customer service, and flexibility in meeting client needs.

We are looking for a Principal Biostatistician to lead clinical trial programs and projects on behalf of our Statistical Operations team. The position is based in Toronto/Markham, Ontario, Canada, or can be performed remotely from anywhere in Canada following our Work‑from‑Home policy.

• Work with the Statistical Operations manager to oversee clinical trial programs for one or more clients.
• Provide day‑to‑day technical and operational leadership to project teams.
• Ensure sound statistical methodology in study design, sample‑size estimation, analysis planning, modeling, and reporting.
• Coach, mentor, and review work of junior biostatisticians and statistical programmers.
• Contribute to protocol design and research proposals.
• Serve as the primary biostatistician on interdisciplinary teams, providing strategic input for drug development and commercialization.
• Review clinical data‑management deliverables, including eCRFs, data validation specifications, data review plans, and data‑management plans.
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodology sections of Clinical Study Reports; perform peer review of others’ technical documents.
• Perform hands‑on statistical analysis and modeling while staying current with regulatory requirements.
• Validate core statistical tables, listings, and figures; conduct quality‑control reviews before release to clients.
• Review and confirm ADaM dataset specifications; perform quality‑control activities on ADaM datasets.
• Provide statistical consultation for medical and clinical trial personnel for publication of results, including abstracts, manuscripts, posters, and presentations.
• Ensure compliance with regulatory requirements and standards (e.g., CDISC) and support sponsor interactions with regulatory agencies.
• Manage statistical and programming resources, conduct capacity analysis, benchmarking, and metrics.
• Participate in continuous improvement of governing documents and in the interview/evaluation process for new hires.

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

Salary Range: $140,000 – $175,000.

Location:

Toronto/Markham, Ontario, Canada or remote within Canada.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities and will provide accommodations upon request.

We thank all interested applicants, however, only those selected for an interview will be contacted.