Senior/Principal Statistical Programmer

Position Title:Senior/Principal Statistical Programmer

Location:Head Office (Toronto, ON)

Status:Full-Time

Summary:

The Principal Statistical Programmer provides high quality programming solutions to support clinical studies in various therapeutic areas. She/he will work closely within a team of SAS programmers and Biostatisticians to support and perform analysis of clinical data.

We are looking for someone who has:

• BA or BSc Degree in Statistics, Math or Computer Science
• Minimum of 4 years’ experience in clinical programming using SAS
• Lead experience overseeing other programmers and projects
• Hands-on experience with CDISC, SDTM and ADaM standards
• CRO experience preferred
• Knowledge of Pinnacle 21
• Strong organizational skills
• High degree of accuracy with timelines and ability to meet deadlines
• Strong verbal and written communication skills
• Strong leadership skills
• Ability to multitask in a fast-paced environment

What you will be doing:

• Act as the Lead Programmer
• Responsible for SDTM package:
  • Author/review/update SDTM specifications
  • Program/review SDTM datasets
  • Validate SDTM datasets
  • Author SDTM reviewer’s guide
  • Assess impact of protocol amendments to SDTM deliverables
• In collaboration with Senior/Principal Biostatistician:
  • Update ADaM specifications
  • Review and QC ADaM datasets programmed by junior staff
  • Review and QC TLFs programmed by junior staff
• Program tables, listings and figures as per SAP for clinical research studies
• Import data from 3rd party clients (e.g. central lab transfers)
• Prepare data exports to be sent to clients
• Perform data checks (quality control) as needed to ensure integrity and accuracy of data displays
• Develop, test, document and maintain a library of SAS statistical macros
• Support CDM group in validation of clinical data
• Undertake project management activities as needed, including managing project team of statistical programmers, ensuring timely completion of deliverables with high quality