Vividion Therapeutics. Inc.

Director

• Provide comprehensive statistical programming leadership and support to clinical project teams
• Deploy programming strategies, standards, specifications, and programmed analyses compliant with regulatory requirements, SOPs, and work practices
• Oversee CRO SAS programming activities and progress to ensure timely, high-quality project delivery
• Oversee CRO efforts related to derived datasets, programs, and analysis dataset specifications
• Oversee development of SAS programs for SDTM and ADaM datasets following CDISC standards
• Oversee development of SAS programs for Tables, Listings, and Figures for clinical trials
• Lead statistical programming activities across multiple studies or a compound
• Lead and support electronic submission preparation and review
• Review statistical analysis plans, mock shells, data review plans, and related programming assumptions and requirements
• Independently develop, validate, troubleshoot, and maintain complex programs and utilities
• Develop robust programming specifications, including ADaM specifications
• Communicate issues and risks proactively and contribute to remediation
• Identify, lead, and support opportunities to enhance processes and technology
• Work closely with the Biometrics Team, Clinical Operations, Regulatory, related disciplines, and CROs
• Report to the Director, Biostatistics

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Associate Director, Statistical Programming