Associate Director Biostatistics

4 weeks ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Associate Director, Biostatistics

Everest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership, and ensuring the delivery of high-quality statistical and programming services.

Key Responsibilities:
  • Manage clinical trial programs and projects, working closely with directors, senior directors, and executive directors to ensure successful project delivery.
  • Provide technical leadership and guidance to project teams, ensuring the delivery of high-quality statistical and programming services.
  • Coach, mentor, and develop direct subordinate biostatisticians and statistical programmers, as well as indirect subordinate biostatisticians and statistical programmers.
  • Perform semi-annual and annual performance reviews, developing developmental plans for direct subordinates and indirect subordinates.
  • Lead statistical and programming teams, interacting with clients and internal project leaders to plan and implement statistical and programming project plans.
  • Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
  • Provide statistical input in protocol design and development, participating in the writing of trial protocols and research proposals.
  • Serve as a principal-level biostatistician, working effectively with interdisciplinary teams to contribute strategically to drug development and commercialization.
  • Review and provide input to clinical data management deliverables, including electronic Case Report Forms, data validation specifications, and Data Management Plans.
  • 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, maintaining expertise in state-of-the-art statistical methodology and regulatory requirements.
  • Validate core statistical tables, listings, and figures programmed by statistical programmers and biostatisticians, ensuring complete and accurate results.
  • Perform overall quality control review on statistical deliverables before release to clients.
  • Review and confirm ADaM dataset specifications, performing QC 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, participating in the writing of abstracts, manuscripts, posters, and presentations.
  • Act as a consultant to less experienced biostatisticians.
  • 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, participating as a statistical liaison to regulatory agencies and ensuring documentation, statistical results, and study datasets meet regulatory requirements.
  • Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.
  • Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
  • Assist in business development activities, including providing cost estimates of statistical and programming services, participating in project proposals and bid defense meetings, and participating in professional trade shows.
  • Participate and/or assist in statistical and programming project budget planning, tracking, and reporting.
  • Perform tracking of out-of-scope services on assigned projects, providing cost estimates, and drafting change orders to existing services work orders.
Qualifications and Experience:
  • A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 10 years' relevant experience or a Master's degree in these fields with at least 13 years' relevant experience.
  • Demonstrated exceptional ability and performance.

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