Position SummaryProvides statistical leadership and support for all phases of clinical development. 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. Lead complex programs such as NDA/BLA/MAA submissions or complex, multi-protocol programs and provide statistical oversight. Serve as a subject matter expert for one or more areas (e.G., Bayesian adaptive study design, Survival analysis, DMC, submissions).Essential FunctionsConsult with clients regarding clinical trial study design and regulatory strategyDevelop and review statistical methods of clinical study protocolsProvide and/or verify sample size calculationsAuthor statistical analysis plans of complex study designReview statistical analysis plans written by other biostatisticiansReview statistical output to ensure accuracyReview statistical sections of clinical study reportsGenerate and/or verify randomization schedulesProvide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatisticianWork proactively with sponsors, internal study team, and external vendorsServe as a Subject Matter Expert (SME) and develop/review procedural documents and work on new initiativesProvide mentoring and training to other statisticiansAttend bid defense meetings for complex programsOther duties as assignedQualificationsMinimum 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.Other RequiredBroad experience with regulatory submissionsExtensive experience consulting with clients regarding clinical trial study design and regulatory strategySuperior understanding of a statistical methodology (e.G., 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 guidelinesExperience with SASPreferredExperience with oncology and rare diseasesExperience with DMCsExcellent communication and interpersonal skillsExcellent problem‐solving skillsExcellent presentation skillsExcellent organizational and time management skillsOutstanding statistical skillsCompetenciesSound judgment/decision makingAbility to establish and teach others to maintain effective working relationships with coworkers, managers, and clientsService oriented, accountable, and flexibleCompetency in written and spoken EnglishFollow and train others on applicable regulations, including FDA, ICH, and Precision Policies and ProceduresAt all times to promote the image of Precision, acting as an ambassador to the CompanyEnsure that all internal systems are routinely updated as appropriate (e.G., timesheets, expense reports, financial reports, etc.)Salary & BenefitsSalary Range: 149,000-246,000discretionary annual bonushealth insuranceretirement savings benefitslife insurance and disability benefitsparental leavepaid time off for sick leave and vacationamong other advantages.Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. 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 [email protected]. #J-18808-Ljbffr

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