Senior Biostatistician - Clinical Research

About this role

• 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.
• **Why join us** **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) **How to Apply** This position is available to fill immediately.
• We welcome applications from qualified professionals seeking full-time or part-time employment, as well as independent consultants interested in project-based or ad-hoc engagements.
• Please indicate your preferred engagement arrangement and availability when applying.
• Applying: As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check.
• If you are sent a skills assessment, please complete it for consideration for the advertised position.
• We thank all applicants for their interest, however, only those selected for an interview will be contacted.

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