Teams at Cytel

Provides statistical strategy and biostatistical oversight for pharmaceutical clinical trials, including protocols, SAPs, clinical study reports, regulatory documentation, analyses, randomization, and vendor deliverables. Develops innovative statistical methodologies and tools, supports clinical development programs, reviews data management documentation, and contributes to cross-functional standards and infrastructure initiatives.

Leads statistical programming for pharmaceutical clinical development programs. Develops and validates SAS or R programs, SDTM and ADaM datasets, tables, listings, figures, specifications, and regulatory submission deliverables. Oversees CRO programming work, supports clinical study reports and FDA submissions, maintains programming standards, contributes to CRF and validation planning, and collaborates with clinical, vendor, and regulatory teams.

Leads complex clinical trial statistical programming using SAS, including TLFs, SDTM and ADaM datasets, Define.xml, regulatory submissions, documentation, quality control, and global utility development. Provides technical and project leadership, ensures compliance with SOPs and FDA/ICH/GCP regulations, supports interactions with regulators and external partners, and independently briefs management on progress and issues.