Teams at Cytel

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.

Lead statistical programming for sponsor clinical trials: develop SDTM/ADaM specs and datasets, author validated SAS/R programs, oversee CRO deliverables, support regulatory submissions, and maintain programming standards and SOPs.

Lead and perform SAS-based data manipulation, analysis, and reporting for Phase I-IV clinical trials. Develop and validate SDTM and ADaM datasets, produce TLFs, perform QC/validation, generate ad-hoc reports, prepare submission documents (define.xml), support efficacy analyses, communicate with cross-functional teams, and perform study lead duties as needed.