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
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
- Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related discipline
Experience
- 5+ 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
- Therapeutic Area: Oncology (primary); will consider Rare Disease, CNS, or Dermatology
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