Arcus Biosciences

Operations

• Support vendor management and oversight of end-to-end safety case processing and safety reporting activities performed by the safety vendor and CROs
• Review safety vendor project plans to ensure processes and procedures are documented appropriately and maintained
• Provide guidance and subject matter expertise to the safety vendor and CROs for safety operational activities
• Monitor safety vendor deliverables and action items to ensure compliance with timelines
• Ensure on-time submission of expedited and aggregate safety reports through effective vendor management and routine review of vendor performance metrics
• Conduct routine retrospective quality control of safety cases processed by the safety vendor to ensure a high quality of safety cases and safety submissions is maintained
• Ensure the safety vendor’s global safety database (Argus) supports Arcus’s needs through oversight of database updates (including MedDRA and WHO Drug updates), study configurations, expedited submissions via safety gateways, and site query management
• Support oversight of safety data exchange with partners in accordance with Safety Data Exchange Agreements (SDEAs)/PV agreements
• Provide safety operational support and expertise to clinical trial study teams as needed, including attending Study Team Meetings and writing/reviewing Safety Management Plans with oversight from Safety Operations leadership
• Collaborate with Data Management to resolve discrepancies identified between the safety and clinical databases via SAE reconciliation
• Partner with Safety Quality and Compliance to ensure inspection readiness
• Collaborate with Arcus partners to support SDEAs/PVAs
• Assist with the preparation of internal/external audits and global regulatory inspections
• Escalate safety noncompliance issues and trends to Safety Quality and Compliance and support investigations of quality issues to ensure appropriate CAPAs.

Manager, Patient Safety and PV Operations

Software Engineer

• The Senior Statistical Programmer Analyst Contractor will be responsible for supporting the submission readiness of study data packages per CDISC standards and FDA guidance, planning, execution, and quality of statistical analyses, and statistical programming infrastructure.
• This position will report into Head of Statistical Programming and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members.
• Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.
• Manage on-time and quality delivery of CRO-generated analyses results.
• Responsible for creating/reviewing SDTM/ADaM mapping specifications. Generates or validates SDTM domains, ADaM datasets, reviewer's guide, and define.xml files.

Senior Statistical Programmer Analyst

• Support of team data review, data reconciliation and edit checks, and programming submission ready SDTM deliverables.
• Build and execute programs for internal data reviews, data reconciliation, and edit checks.
• Assist in developing/maintaining clinical programming related standards and tools.
• Work with data management to review case report forms, database specifications and similar documents.
• Develop data transfer specifications and manage the transfer of external data.
• Program SDTM datasets and produce related CDISC deliverables such as aCRF, define.xml, reviewer’s guide, etc.
• Perform stakeholder management, negotiating timelines and scope of deliverables.
• Participate in standards governance and developing biometric department operational processes.

Senior Clinical Programmer – Contractor

Engineer

• Process and QC high-dimensional datasets to expand internal databases
• Maintain and improve internal pipelines for data processing
• Develop standardized internal pipelines for processing of additional data types
• Work closely with Bioinformatics Scientists on improving internal processes and databases
• Collaborate with constituencies in IT and Scientific Computing to improve infrastructure
• Serve as the technical resource for optimizing pipelines and developing reproducible frameworks

Manager, Patient Safety and PV Operations

Senior Statistical Programmer Analyst

Senior Clinical Programmer – Contractor

Bioinformatics Engineer