Senior Statistical Programmer

Position: 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 robust 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   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

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