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
• Support statistical programming infrastructure
• Interact with internal and external biostatisticians, clinical data managers, and other team members
• Prioritize work and communicate and collaborate with stakeholders across Biometrics, research, translational science, clinical science, clinical operations, and regulatory
• Develop specifications and build and execute programs for internal data reviews, publications, exploratory and post-hoc analyses, and regulatory review
• Produce and prioritize study-level or integrated analytical deliverables for safety signal detection and other business needs
• Work with data management to review case report forms, database specifications, and data transfer specifications
• Manage on-time and quality delivery of CRO-generated analysis results
• Create and review SDTM/ADaM mapping specifications
• Generate or validate SDTM domains, ADaM datasets, reviewer’s guides, and define.xml files
• Generate or validate TFLs supporting clinical study analyses, regulatory submissions, and publications including CSR, DSUR, and IB

Senior Statistical Programmer Analyst – Contractor