Senior Statistical Programmer

We are seeking a well-rounded Statistical Programmer to join a fast-moving clinical programming team supporting multiple clients and study types. This is a client-facing role requiring strong communication skills alongside deep technical expertise. The ideal candidate is adaptable, independently driven, and comfortable shifting between FSP and in-house environments — often with different standards and expectations client to client. Candidates must be based in Canada.

Key responsibilities

Statistical programming

• Participate in all statistical programming activities across the full clinical data lifecycle, from raw data to submission
• Develop SAS programs for SDTM conversions, ADaM analysis datasets, and study TFLs based on SAPs, shells, and CDISC or client-specific instructions
• Develop core programs for validation, conversion, and maintenance of clinical data dataset structures
• Create programming specification documents for all data types including SDTM, ADaM, and derived data
• Review and verify all conversions and programming outputs against customer requirements

Submissions & standards

• Prepare clinical data for regulatory submissions using CDISC or customized standards
• Prepare submission documents including Reviewer's Guides and Define.xml
• Contribute to the development of best practices and implementation guides

Project management & mentorship

• May be responsible for project or program-level management including timelines, scope, budget, and resourcing
• Train, mentor, and share knowledge with other members of the statistical programming team
• Interact directly with clients at the project or program level as needed

Compliance

• Follow applicable Standard Operating Procedures (SOPs) for all statistical programming activities

Education

• Bachelor's degree in Statistics, Computer Science, Life Sciences, or a related discipline

Experience

• 6+ years of experience as a statistical programmer working on clinical trials; candidates with 4–5 years may be considered with a strong track record of rapid career progression
• Solid TFL programming experience
• Experience programming to CDISC standards (SDTM, ADaM) and preparing regulatory submission documents
• Experience working across FSP and in-house environments, or across multiple client engagements

Skills

• Strong SAS programming skills across the full end-to-end clinical programming workflow
• Excellent client-facing communication skills — written and verbal
• High attention to detail with the ability to review and validate complex programming outputs
• Adaptable and comfortable operating in fast-changing environments across different client standards and expectations