Remote Director of Statistical Programming

Puma Biotechnology; Los Angeles (CA); Remote; USD 220,000 - 250,000; Full time

Job summary

Puma Biotechnology, Inc. in the Los Angeles area seeks a Director of Statistical Programming to provide strategic and technical leadership for the Statistical Programming function, ensuring timely delivery of high-quality programming deliverables in support of clinical development and regulatory submissions.

This role oversees datasets, TLFs, and standards, and manages statistical programmers. It partners with the biometrics head on budgeting and resource planning, and coordinates

Qualifications

• BS in Mathematics, Computer Science, Statistics, or related field.
• 8+ years progressive statistical programming experience.
• Experience leading a team of statistical programmers.
• Expert knowledge of CDISC SDTM/ADaM and regulatory standards.
• Proficiency with EDC and SAS programming.

Responsibilities

• Represent programming at study team meetings and collaborate cross-functionally.
• Create datasets, TLFs, and respond to regulatory requests and inquiries.
• Apply and promote consistent programming standards via SOPs.
• Maintain documentation surrounding clinical data and programs.
• Manage budget and resources for the statistical programming area.
• Coordinate workloads to meet company goals.

Skills

Leadership

SAS

CDISC SDTM/ADaM

EDC

Budget & planning

Regulatory knowledge

Education

BS in Mathematics/CS/Statistics

MS in Biostatistics (preferred)

Tools

SAS (Base/STAT/GTL/Macro)

Windows/UNIX

Remote server access

Job description

Puma Biotechnology, Inc. in the Los Angeles area seeks a Director of Statistical Programming to provide strategic and technical leadership for the Statistical Programming function, ensuring timely delivery of high-quality programming deliverables in support of clinical development and regulatory submissions.

This role oversees datasets, TLFs, and standards, and manages statistical programmers. It partners with the biometrics head on budgeting and resource planning, and coordinates