Statistical Programming Director

3 weeks ago


Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Associate Director, Statistical Programming

Everest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Statistical Programming to join our team. As a key member of our Statistical Programming department, you will be responsible for managing clinical trial programs and projects from start to finish, ensuring timely and within-budget deliveries.

Key Responsibilities:
  • Lead statistical programming teams in planning and implementing project plans, ensuring quality and timely deliverables within budget.
  • Implement CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas.
  • Support electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses.
  • Develop and deliver training curricula and governing documents (Standard Operating Procedures, Work Instructions, Templates, etc.)
  • Perform quality control (QC) review of statistical programming deliverables, including documentation, before they are released for production, delivered to clients, or submitted to regulatory agencies.
Requirements:
  • At least a bachelor degree and preferred to have M.Sc., M.A. or higher in Statistics, Computer Science, or relevant fields with at least 14 years of clinical research experience.
  • Demonstrated experience and success in leading statistical programming teams in planning and implementing statistical programming project plans, leading programming teams to generate and deliver quality and timely deliverables within budget.
  • Demonstrated experience implementing CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas.
  • Demonstrated experience supporting electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses.
Travel Level Specification:

This position may require up to 10% business travel.



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