Arcus Biosciences

Software Engineer

• Support submission readiness of study data packages per CDISC standards and FDA guidance
• Plan, execute, and ensure quality of statistical analyses and programming infrastructure
• Report to Head of Statistical Programming and communicate with biostatisticians, clinical data managers, and team members
• Develop specifications and execute programs for data reviews, publications, exploratory analyses, post-hoc analyses, and regulatory review
• Manage on-time and quality delivery of CRO-generated analyses results
• Create/review SDTM/ADaM mapping specifications, generate/validate SDTM domains, ADaM datasets, reviewer's guide, and define.xml files
• Generate/validate TFLs for statistical analysis of clinical data, regulatory submissions, and publications

Senior Statistical Programmer Analyst, Contractor