Director, Statistical Programming — Lead Oncology Data

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

Benefits offered by this job

401K + Employer contributions

Generous stock options

PTO 20 days to start

Holidays (18)

Job summary

Kura Oncology, Inc. in San Diego is seeking a Director of Statistical Programming to provide top‑level programming leadership for clinical development.

You will collaborate across biostatistics, data management, CROs, and internal teams to deliver CDISC submission packages and ensure regulatory readiness. The role requires extensive SAS expertise, deep knowledge of CDISC/ICH/GCP/21 CFR Part 11, and a track record in regulatory submissions.

Qualifications

• MS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 10–12 years of programming experience in the pharmaceutical industry; or BS with 12+ years.
• Advanced SAS programming in a clinical data environment.
• Extensive knowledge of CDISC, ICH, GCP, and 21 CFR Part 11 rules.
• Ability to leverage AI and automation tools to enhance efficiency.
• Regulatory submission standards knowledge.

Responsibilities

• Provide leadership and programming support to Clinical Development.
• Lead design, development, and validation of CDISC submission packages.
• Lead projects from study start-up to regulatory submission and post-marketing support.
• Mentor junior staff and participate in recruitment for programmer positions.

Skills

SAS programming

CDISC

ICH/GCP/21 CFR Part 11

AI/automation tools

Regulatory knowledge

Education

MS in Statistics/CS/Math/Engineering/Life Science

BS in Statistics/CS/Math/Engineering/Life Science

Tools

AI tools

Job description

Kura Oncology, Inc. in San Diego is seeking a Director of Statistical Programming to provide top‑level programming leadership for clinical development.

You will collaborate across biostatistics, data management, CROs, and internal teams to deliver CDISC submission packages and ensure regulatory readiness. The role requires extensive SAS expertise, deep knowledge of CDISC/ICH/GCP/21 CFR Part 11, and a track record in regulatory submissions.