Senior Statistical Advisor

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Statistical Advisor based in Canada . The Senior Statistical Advisor plays a key role in shaping the statistical strategy and methodology behind Phase I–IV clinical trials. You will provide expert statistical guidance throughout clinical development, from protocol design and sample size calculations to data analysis and interpretation. Working closely with clinical research teams, scientific writers, and external sponsors, you will help ensure that studies generate reliable, meaningful, and scientifically robust results. Your expertise will contribute to the development of efficient, cost-effective clinical trials and support the preparation of high-quality regulatory submissions. You will also help strengthen statistical standards, improve internal processes, and ensure compliance with applicable regulations and industry guidelines. This position offers the opportunity to apply advanced statistical knowledge in a collaborative clinical research environment focused on scientific quality and sponsor satisfaction. It is an excellent opportunity for a statistics professional seeking to make a meaningful impact on clinical research and drug development. Accountabilities - Clinical trial design and statistical strategy: Provide statistical expertise for Phase I–IV clinical trials, including protocol development, trial design, sample size estimation, power calculations, randomization strategies, and selection of appropriate statistical methods. - Statistical analysis and interpretation: Review statistical analysis plans and validate statistical outputs to ensure accuracy, consistency, and scientific integrity.

Interpret clinical trial results and communicate findings clearly to technical and non-technical stakeholders. - Sponsor and client collaboration: Communicate with sponsors and clients regarding study protocols, statistical methodologies, analytical approaches, and other statistical issues, ensuring alignment with project objectives and expectations. - Regulatory and submission support: Contribute statistical expertise to clinical development activities and regulatory submissions, ensuring compliance with applicable regulatory requirements, industry guidelines, and internal standard operating procedures. - Clinical study reporting: Support scientific writers in preparing Clinical Study Reports by reviewing statistical results, clarifying analytical concepts, and ensuring the accurate presentation of study findings. - Research and methodological improvement: Advise on the design of valid, efficient, and cost-effective clinical trials and other research projects. Contribute to the development and standardization of statistical methodologies, reporting formats, and internal procedures. - Cross-functional teamwork: Collaborate with clinical trial implementation teams and other stakeholders to support high-quality study delivery, meet project timelines, and address statistical challenges effectively. - Continuous learning and development: Stay informed about emerging statistical methods, clinical drug development practices, scientific literature, and evolving regulatory guidance to strengthen statistical expertise and improve research outcomes. Requirements - Education and statistical expertise: A strong academic background in statistics, biostatistics, or a related quantitative discipline is expected, with the advanced statistical knowledge needed to support clinical trial design, analysis, and interpretation. - Clinical research knowledge: Experience or demonstrated expertise in clinical trial methodology, particularly across Phase I–IV development, including protocol design, sample size calculations, statistical power, randomization, and statistical analysis planning.