Statistical Programmer

Connect Life Sciences; Quebec; On-site; CAD 80,000 - 105,000; Full time

Job summary

Connect Life Sciences is seeking an experienced statistical programmer to support clinical trials in Canada. This role requires at least 6 years of experience in statistical programming, with a strong knowledge of TFL programming and CDISC standards (SDTM, ADaM).

The candidate will participate in all phases of statistical programming activities, contribute to project management, train team members, and develop SAS programs for data conversion and analysis. A bachelor's degree in statistics, computer science, or life sciences is required.

Qualifications

• Minimum 6 years' experience in statistical programming for clinical trials.
• Knowledge of TFL programming and CDISC standards (SDTM, ADaM).

Responsibilities

• Prepare clinical data for submission using CDISC or customized standards.
• Manage project timelines, scope, and resources.
• Train and mentor the statistical programming team.
• Create programming specification documents for SDTM, ADaM, etc.
• Interact with customers on projects.
• Develop SAS programs for clinical data conversion.
• Review and verify conversions and programming.
• Ensure adherence to Standard Operating Procedures for all activities.

Skills

Statistical programming

TFL programming

CDISC standards

SAS programming

Education

Bachelor's degree in statistics, computer or life science

Job description

• Minimum 6 years’ experience as a statistical programming working on clinical trials.
• Good knowledge of TFL programming.
• Experience in programming according to CDISC standards (SDTM, ADaM), and preparing documents for submission (Reviewer’s Guide, Define.xml)
• A bachelor’s degree in either statistics , computer or life science discipline

Duties will include:

• Participating in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.
• Might need to be responsible for project management (timelines, scope, budget, resourcing) on a project or program level.
• Train, mentor and share knowledge with the rest of the statistical programming team.
• Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc.).
• Might include Interaction with customers on a project or program level.
• Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.
• Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.
• Development of SAS programs for study TFLs, based on study SAP and shells.
• Review and verify all types of conversions and programming done based on customer requirements.
• Development of core programs for validation, conversion, and maintenance of clinical data dataset structure.
• Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.