Specific responsibilities include consulting with clients regarding clinical trial study design and regulatory strategy, writing and reviewing statistical methods and sample size sections of protocols, writing and reviewing statistical analysis plans of complex study designs, reviewing statistical analyses and presenting statistical results. Serve as a subject matter expert for one or more areas (e.g., Bayesian adaptive study design, Survival analysis, DMC, submissions). Consult with clients regarding clinical trial study design and regulatory strategy Provide and/or verify sample size calculations Author statistical analysis plans of complex study design Review statistical analysis plans written by other biostatisticians Generate and/or verify randomization schedules Provide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician Serve as a Subject Matter Expert (SME) and develop/review procedural documents and work on recent initiatives Provide mentoring and training to other statisticians Minimum Required: Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience; PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience.

Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics,



or related field with 7+ years experience. Broad experience with regulatory submissions Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy Bayesian adaptive study design, Survival analysis, Repeated measures) Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines Service oriented, accountable, and versatile Competency in written and spoken English Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures discretionary annual bonus health insurance retirement savings benefits life insurance and disability benefits parental leave paid time off for sick leave and vacation Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.

📌 Principal Biostatistician/Senior Principal Biostatistician (Toronto)
🏢 Precision for Medicine
📍 Toronto