Remote Principal Statistical Programmer — CDISC/Oncology Lead

Puma Biotechnology, Inc.; Los Angeles (CA); Remote; USD 175,000 - 210,000; Full time

Job summary

Puma Biotechnology, Inc. is seeking a Principal Statistical Programmer to collaborate with biostatistics teams, CRAs, data managers and regulatory staff to meet study deliverables and timelines for data analysis and reporting. This is a remote position with a home-office setup.

The role requires 12+ years of clinical trial programming experience, a CS/Math/Statistics degree, CDISC (SDTM/ADaM) expertise in Oncology, and advanced SAS macro skills; proficiency in Python, R, and JavaScript is a plus.

Qualifications

• Bachelor degree in CS/Math/Statistics or related quantitative field.
• Minimum of 12 years of clinical trial programming experience.
• Strong knowledge of CDISC (SDTM/ADaM) in Oncology.
• Experience with regulatory submissions and data standards.

Responsibilities

• Generate or oversee statistical output for study reports.
• Ensure programming and documentation meet procedures.
• Lead development of SAS macros for standard outputs and CDISC.
• Contribute to SAS Programming Work Instructions and Standards.
• Produce listings for data checking and data quality.
• Develop techniques using Python, R, or JS to enhance analysis.
• Provide ad-hoc data outputs for regulatory needs.
• Attend study team meetings as primary statistical programming contact.

Skills

Organizational skills

Prioritization

Communication skills

CDISC (SDTM/ADaM)

Education

Bachelor's degree in Computer Science, Mathematics, Statistics or related quantitative field

Tools

SAS

Python

R

JavaScript

Job description

Puma Biotechnology, Inc. is seeking a Principal Statistical Programmer to collaborate with biostatistics teams, CRAs, data managers and regulatory staff to meet study deliverables and timelines for data analysis and reporting. This is a remote position with a home-office setup.

The role requires 12+ years of clinical trial programming experience, a CS/Math/Statistics degree, CDISC (SDTM/ADaM) expertise in Oncology, and advanced SAS macro skills; proficiency in Python, R, and JavaScript is a plus.