Remote Senior Biostatistician: Clinical Trials Leader

dicentra Inc.; Canada; Remote; CAD 110,000 - 170,000; Full time

Job summary

dicentra is seeking an experienced Senior Biostatistician to lead statistical activities across a diverse pipeline, including pharmaceuticals, natural health products, and medical devices. The role offers flexible engagement—full-time, part-time, or independent consulting—fully remote from Ontario.

You will design studies, develop SAPs, review data management, perform analyses, and contribute to CSRs and regulatory responses, with independence and scientific rigor at the core.

Qualifications

• Master’s or Ph.D. in Biostatistics, Statistics, Mathematics, or a related quantitative field.
• Demonstrated experience leading biostatistics across clinical trials in one or more areas: pharmaceuticals, medical devices, or natural health products / supplements.
• Proficient in SAS, R, or equivalent clinical statistical analysis software.
• Strong working knowledge of standard clinical trial principles (ICH GCP, ICH E9) applicable to clinical research and health authority submissions.
• Ability to distill complex statistical concepts into clear, actionable takeaways for medical writers and clinical teams.
• Independent management of statistical assignments, meeting timelines with minimal supervision.

Responsibilities

• Study Design & Protocol Development: Calculate sample size and power, design randomization schemes, author statistical sections for protocols across pharma, medical device, and NHP trials.
• Develop and finalize SAPs, including mock TLFs.
• Review EDC setup, eCRF designs, and data management specifications.
• Conduct statistical analyses, interpret findings, and draw defensible conclusions.
• Author statistical methods and results for CSRs and support regulatory responses.
• Provide quick feasibility and design input for proposals and regulatory meetings.
• Ensure methodologies and deliverables meet scientific, regulatory, and quality standards.

Skills

Biostatistics leadership

Communication

Independent project delivery

Education

Master’s or Ph.D. in Biostatistics/Statistics/Mathematics

Tools

SAS

R

Job description

dicentra is seeking an experienced Senior Biostatistician to lead statistical activities across a diverse pipeline, including pharmaceuticals, natural health products, and medical devices. The role offers flexible engagement—full-time, part-time, or independent consulting—fully remote from Ontario.

You will design studies, develop SAPs, review data management, perform analyses, and contribute to CSRs and regulatory responses, with independence and scientific rigor at the core.