Sr Statistical Programmer, Oncology

Connect Life Sciences; United States; On-site; CAD 90,000 - 120,000; Full time

Job summary

Connect Life Sciences is seeking a well-rounded Statistical Programmer to join a fast-moving clinical programming team supporting multiple clients and study types. This client-facing role requires strong communication 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.

Qualifications

• 5+ years of experience as a statistical programmer on clinical trials.
• Solid experience with SDTM and ADaM datasets and TFLs.
• Experience with CDISC standards and regulatory submissions.
• Experience across FSP and in-house client engagements.

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.
• 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.
• 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.

Skills

SAS programming

Client-facing communication

Attention to detail

Adaptability

Education

Bachelor's or Master's degree in Statistics/Biostatistics/Computer Science/Mathematics

Job description

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 U.S. OR Canada - No sponsorship or Corps at this time***

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
• 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

Bachelors or 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 documentsExperience working across FSP and in-house environments, or across multiple client engagements

Therapeutic Are

a: Oncology (primary)

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