Teams at Cytel

The Principal Statistical Programmer develops and validates SAS and R programs, SDTM and ADaM datasets, specifications, tables, listings, graphs, Define.xml files, and reviewer’s guides for clinical trials. The role supports regulatory submissions, clinical study reports, data validation, CRF and edit-check development, vendor data transfers, and CRO oversight. It requires extensive oncology expertise, independent ownership of multiple studies, compliance with FDA and CDISC standards, and collaboration across global clinical development teams.

Independently leads statistical programming for pharmaceutical clinical development studies. Develops and validates SAS and R programs, SDTM and ADaM datasets, specifications, tables, listings, graphs, and regulatory submission deliverables. Oversees CRO programming work, supports clinical study reports and FDA submissions, maintains programming standards, contributes to CRFs and validation plans, and collaborates with clinical, regulatory, vendor, and development teams.

Develop automation and AI solutions supporting pharmaceutical clinical trials. Interpret requirements, identify workflow improvements, build proof-of-concept tools using R, Shiny, and LLM-supported coding, and mature successful prototypes into validated, documented, reusable solutions. Collaborate with statisticians, programmers, data scientists, and AI leads while ensuring testing, traceability, audit trails, version control, and compliance with regulated clinical development expectations.