Senior Biostatistical Consultant

5 days ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
About Everest Clinical Research Services Inc

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. With a strong foundation in statistical and data management expertise, we have established ourselves as a trusted partner for clients worldwide.

Job Title: Principal Biostatistician

We are seeking a highly skilled Principal Biostatistician to join our team in Toronto/Markham, Ontario, Canada or remotely from a home-based office in Canada. As a key member of our Statistical Operations management team, you will be responsible for managing clinical trial programs/projects from one or multiple clients.

Key Responsibilities:
  • Provide technical and operational leadership to project teams supporting clinical trial programs/projects.
  • Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
  • Coach, mentor, and develop less experienced Biostatisticians and Statistical Programmers.
  • Provide statistical input in protocol design and development, and participate in writing trial protocols and research proposals.
  • Contribute strategically to drug development and commercialization through innovative ideas and applications.
  • Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, 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 release to clients.
  • Provide statistical consultation to medical and clinical trial personnel for publication of trial results, and participate in writing abstracts, manuscripts, posters, and presentations.
  • Ensure compliance with relevant regulatory requirements and applicable standards/conventions.
  • Interact with regulatory agencies and support sponsor in new drug application.
Qualifications and Experience:
  • 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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