Director, Statistical Programming

Responsibilities

• Provide technical leadership and programming support to Clinical Development
• Collaborate with biostatisticians, data managers, and CRO vendors on statistical programming deliverables
• Lead design, development, and validation of CDISC submission packages
• Review CRO statistical programming deliverables for adherence to SAP and CDISC standards
• Mentor junior staff on programming techniques and project management
• Manage program resources, including assigning programmers and overseeing timelines
• Implement quality control procedures in compliance with regulatory requirements

Requirements

• MS in Statistics, Computer Science, Mathematics, Engineering, or Life Science with 10-12 years of pharmaceutical programming experience
• BS in a related field with 12+ years of pharmaceutical programming experience
• Advanced SAS programming skills in a clinical data environment
• Extensive knowledge of CDISC, ICH, GCP, and 21 CFR Part 11
• Knowledge of regulatory requirements for electronic submission standards
• Ability to leverage AI and automation tools for workflow efficiency

Preferred Qualifications

• Experience in ad-hoc programming for rapid analysis
• Thorough understanding of Phase I-IV clinical drug development
• Experience delivering global regulatory submissions
• Experience in Acute Myeloid Leukemia (AML) oncology
• Strong ability to influence stakeholders and lead cross-functional collaboration

About the Company

Kura Oncology is a commercial-stage biopharmaceutical company dedicated to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.