Director of Statistical Programming — Oncology Impact

Kura Oncology; San Diego (CA); On-site; USD 234,644 - 263,000; Full time

Benefits offered by this job

Competitive compensation package

Bonus

401K + Employer contributions

Generous stock options

20 days PTO to start

18 holidays

Job summary

Kura Oncology is seeking a seasoned Director of Statistical Programming in California to lead data programming for clinical development across indications. You will collaborate with statisticians, data managers, CROs, and internal teams to create, implement, and maintain programming deliverables, including CDISC submissions, while driving process improvements and maintaining regulatory compliance.

The role requires extensive SAS expertise, CDISC knowledge, and a track record of leading programs

Qualifications

• MS/BS with extensive pharma programming experience
• Advanced SAS in clinical data environment
• CDISC, ICH, GCP, 21 CFR Part 11 knowledge
• Experience with AI/automation in programming
• Regulatory submission experience and familiarity with submission standards

Responsibilities

• Provide leadership and support to project teams on data programming matters.
• Communicate with CRO vendors and internal teams for updates and quality.
• Lead programming deliverables from study start-up to regulatory submission and post-marketing support.
• Design, develop, and validate CDISC submission packages.
• Review CRO deliverables for adherence to SAP, CDISC standards, and submissions readiness.
• Develop programming standards/macros and contribute to process improvements.
• Ensure compliance with internal standards and resource planning.
• Mentor junior staff and participate in recruitment of programmers.
• Represent programming in multidisciplinary study teams for regulatory support.
• Develop data models and train end users on project standards.
• Implement quality control procedures compliant with regulatory requirements.

Skills

Advanced SAS

CDISC ICH GCP

Regulatory submissions

Project leadership

Mentoring

Communication

AML oncology

Education

MS in Statistics/CS/Engineering or related (10–12 years)

BS in Statistics/CS/Engineering or related (12+ years)

Tools

SAS

Job description

Kura Oncology is seeking a seasoned Director of Statistical Programming in California to lead data programming for clinical development across indications. You will collaborate with statisticians, data managers, CROs, and internal teams to create, implement, and maintain programming deliverables, including CDISC submissions, while driving process improvements and maintaining regulatory compliance.

The role requires extensive SAS expertise, CDISC knowledge, and a track record of leading programs