Teams at Cytel

Lead sponsor-dedicated statistical programming for clinical trials: create SDTM/ADaM specifications and datasets, develop and validate SAS programs, oversee CRO deliverables, support regulatory submissions and study reports, maintain programming standards, and collaborate across clinical and vendor teams.

Lead or support Phase I-IV clinical trial programming using SAS and CDISC standards to generate and validate SDTM/ADaM datasets, produce TLFs, perform QC/validation, create submission documents (define.xml), and communicate with cross-functional teams. Provide ad-hoc reports, efficacy analyses, and occasional study lead duties while working collaboratively in a global, remote environment.

Lead statistical activities for vaccine clinical development: author and review SAPs, analyze SDTM/ADaM data, produce TLFs, support regulatory submissions, and coordinate with sponsor teams.