Senior Biostatistician – Clinical Research

dicentra Inc.; Canada; À distance; CAD 110 000 - 170 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Biostatistics leadership

Communication

Independent project delivery

Formation

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

Outils

SAS

R

Description du poste

For over 25 years, dicentra has been a trusted global leader in regulatory consulting and clinical research for the life sciences and health product industries. We partner with innovators worldwide to navigate complex regulatory landscapes, turn scientific rigor into commercial success, and bring safe, compliant products to market.

We have an immediate opening for an experienced Senior Biostatistician to support our clinical trials through a flexible engagement arrangement. We welcome applications from professionals interested in full-time or part-time employment, as well as independent consultants available for project-based or ad-hoc assignments.

The Opportunity

In this role, you will serve as the primary statistical authority across a diverse pipeline of clinical studies spanning pharmaceuticals, natural health products (NHPs) / dietary supplements, and medical devices.

You will provide end-to-end statistical leadership—designing study methodologies, consulting on data capture structures, executing data analyses to draw actionable conclusions, and contributing directly to study protocols and Clinical Study Reports (CSRs).

The scope and level of involvement will be determined based on project requirements and the agreed engagement arrangement, offering opportunities for both ongoing collaboration and individual project assignments.

Key Responsibilities

• Study Design & Protocol Development: Calculate sample size and statistical power, design randomization schemes, and author statistical sections for clinical protocols across pharma, medical device, and NHP trials.
• Statistical Analysis Plans (SAPs): Develop and finalize comprehensive SAPs, including mock Table, Listing, and Figure (TLF) shells.
• EDC & Data Management Review: Review EDC setup, eCRF designs, and data management specifications to ensure clinical databases align with planned analyses and endpoints.
• Data Analysis & Interpretation: Conduct statistical analyses on trial data, interpret findings, evaluate significance, and draw clear, defensible scientific conclusions.
• Reporting & Regulatory Contributions: Author statistical methods and results sections for Clinical Study Reports (CSRs) and support regulatory responses to Health Canada, FDA, or ethics committees/IRBs.
• Ad-Hoc Consulting: Provide quick-turnaround statistical feasibilities, study design critiques, and input for client proposals and regulatory meetings.
• Statistical Quality & Oversight: Ensure statistical methodologies, analyses, and deliverables meet applicable scientific, regulatory, and quality standards.

Qualifications & Background

• Education: Master’s or Ph.D. in Biostatistics, Statistics, Mathematics, or a related quantitative field.
• Experience: Demonstrated experience leading biostatistics across clinical trials in one or more areas: pharmaceuticals, medical devices, or natural health products / supplements.
• Statistical Analysis Tools: Proficient in clinical statistical analysis software such as SAS, R, or equivalent tools, with the ability to reliably process trial datasets and generate report deliverables.
• Regulatory Understanding: Strong working knowledge of standard clinical trial principles (such as ICH GCP and ICH E9 statistical principles) applicable to clinical research and health authority submissions.
• Communication: Ability to distill complex statistical concepts into clear, actionable takeaways for medical writers, clinical operations teams, and client sponsors.
• Independent Project Delivery: Demonstrated ability to manage statistical assignments independently, meet agreed timelines, and deliver high-quality work with minimal supervision.

Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.

Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.

Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.

Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!

Job Type: Full-Time Employment, Part-Time Employment, or Independent Consulting Contract (Project-Based / Ad-Hoc)

Location: Ontario (Fully Remote)

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