Teams at Cytel

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.

Support Phase I and IIa clinical studies and biomarker development through study design contributions, analysis planning, statistical analyses, reporting, quality control, documentation review, and exploratory analyses. Use SAS and R to analyze and interpret results, ensure deliverable quality, and communicate statistical methods and findings to pharmaceutical sponsors and stakeholders. May lead study or publication activities.

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.