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Statistical Programmer Lead

2 months ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Summary

We are seeking a highly skilled and experienced Statistical Programmer Lead to join our team at Everest Clinical Research Services Inc. As a key member of our programming team, you will be responsible for leading complex statistical programming projects and ensuring the delivery of high-quality results.

Key Responsibilities
  • Lead projects with higher levels of complexity, challenge, and difficulty, and lead efforts to resolve complex statistical programming issues or problems.
  • Apply project management skills and statistical programming techniques to lead assigned projects, achieving on-time delivery of deliverables with quality, and earning client trust and repeat business.
  • Represent the company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates, and proposal development.
  • Under supervision, represent the company to interact with regulatory agencies regarding matters relating to responsible projects/programs.
  • Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
  • Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company or client Standard Operating Procedures (SOPs) and project-specific requirements.
  • Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.
  • Perform CDISC standard compliant checks on SDTM and ADaM datasets, generate, review, and resolve Pinnacle 21 validation issues, and perform additional QC checks using company Working Instruction (WI) checklists.
  • Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.
  • Create SDTM and ADaM define.xml files, and table of contents, and perform QC review of these files prepared by others.
  • Participate and/or lead programming teams in support of product regulatory submission related activities.
  • Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.
  • Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers, develop new macros and utilities.
  • Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.
  • Complete job-required and project-specific training, comply with applicable Everest and trial Sponsor's Policies, SOPs, and WIs.
  • Document data and programming information in accordance with corporate SOPs and guidelines.
  • Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.
  • May lead programming efforts for assigned client clusters when required.
Qualifications

A Master's or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least 8 years of experience in clinical trial statistical programming, or a Bachelor's degree in the above fields with at least 10 years of experience in clinical trial statistical programming.