Senior Biostatistician – Clinical Research

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.

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.

• 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.

• 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.

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