Sr Statistical Programmer, Oncology

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 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 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 documents Experience working across FSP and in-house environments, or across multiple client engagements Therapeutic Area: 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

The role involves developing SAS programs for SDTM, ADaM, and TFLs across the full clinical data lifecycle for oncology trials. Responsibilities include preparing regulatory submission documents and managing client interactions and project timelines.

Candidates need a degree in Statistics or a related field and at least 5 years of experience in clinical trial statistical programming. Proficiency in CDISC standards and experience working in FSP or in-house environments are required.

• Gestion de projetSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• SAS Programming
• CDISC Standards
• SDTM
• ADaM
• TFL Programming
• Clinical Data Lifecycle
• Regulatory Submissions
• Oncology
• Client Communication
• Project Management
• Mentorship
• Define.xml
• Reviewer's Guides
• Data Validation
• Programming Specifications
• SOP Compliance

• Science & Research
• Healthcare
• Data & Analytics
• Consulting
• Software

Formation minimale

Baccalauréat

Expérience minimale

5+ ans

Postuler avant le

13 sept. 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Mid-Senior level

Mode de candidature

La candidature directe est offerte