Senior Biostatistician

1 month ago

Markham, 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, Ontario, 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 day-to-day technical and operational leadership to project teams supporting these programs/projects.
  • Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring 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 as well as Statistical Programmers assigned to the program/projects.
  • Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
  • Serve as a primary biostatistician, working effectively with interdisciplinary teams to 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 but not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the 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, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients.
  • Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
  • Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.
  • Ensure all study level as well as 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 sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency's requirement/expectation (e.g., CDISC).
  • Perform statistical and programming resource management, capacity analysis, benchmarking, and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.
  • Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
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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