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Statistical Programmer Analyst - Clinical Data Management

Toronto, ON
On behalf of our client, a leading North American provider of Clinical Data Management company serving the Biotechnology, Pharmaceutical and Medical Devices industries, we are recruiting for a Statistical Programmer Analyst to join this highly respected and growing organization.

  • Prepare SDTM/ADaM specification documents
  • Review SDTM/ADaM specification documents and provides feedback to the Project Manager and appropriate project team members
  • Perform SDTM/ADaM validation checks via SAS programming
  • Review SDTM/ADaM validation issues and provide resolutions to issues
  • Review SDTM mapping of eCRF
  • Assist/Prepare SDTM/ADaM submission packages (reviewer’s guide, define.xml, etc.)
  • Program SDTM, ADaM, TLF and other statistical programming
  • Perform quality control self-checks to ensure that all output meets quality standards and project requirements
  • Assist in the review of project documentation (TLF shells, TLF outputs, etc.) to ensure output meets quality standards and project requirements
  • Update QC logs with proposed resolutions/actions to QC findings for TLFs
  • Develop specifications and programs for data transfers and assist in their review to ensure the datasets meet the specifications Perform high-level data-driven and content review of all statistical programming deliverables, identify and resolve issues
  • Act as project-specific manager of SDTM tasks ensuring all tasks and timelines are maintained
  • Provide updates to Project Manager on SDTM tasks
  • Provide project-specific SDTM expertise at Sponsor TCs and meetings

Required Skills/Experience
  • 3-5+ years of experience with SAS in Pharmaceutical/Biotech Industry
  • Knowledge of CDISC including SDTM/ADaM standards
  • Experience writing SDTM/ADaM specifications
  • Ability to troubleshoot SDTM/ADaM data validation issues
  • Knowledge of clinical data management, including data validation techniques
  • Detail oriented, high level of accuracy
  • Effective interpersonal and collaborative skills
  • Ability to handle multiple projects and deadlines
  • Strong technical writing skills
  • Demonstrated project management skills
We thank all applicants for their interest and will contact all who are qualified to discuss further.
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