Biostatistician Leader

14 hours ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Principal Biostatistician

Everest Clinical Research Services Inc is seeking a highly skilled Principal Biostatistician to join our team in Toronto/Markham, Ontario, Canada or remotely from a home-based office anywhere in Canada.

Key Responsibilities:
  • Manage clinical trial programs/projects from one or multiple clients, working closely with the Statistical Operations management team.
  • Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
  • Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
  • Coach, mentor, develop, and provide technical review, advice, and expertise to less experienced Biostatisticians and Statistical Programmers.
  • Participate in the writing of trial protocols and research proposals.
  • Contribute strategically to drug development and commercialization at the study and drug compound/therapeutic areas levels.
  • Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan, and Data Management Plan.
  • Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
  • Perform peer review of SAPs and other technical documents written by others.
  • Perform hands-on statistical analysis and modeling, and maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
  • Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians.
  • Perform overall Quality Control review on statistical deliverables before they are released to clients.
  • Provide statistical consultation to medical and clinical trial personnel for the publication of trial results.
  • Ensure all study-level and drug program-level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
  • Interact with regulatory agencies and support sponsors in new drug applications.
Requirements:
  • A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 7 years of relevant experience.
  • OR A Master's degree in the above fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance.

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