Remote Senior Statistical Programmer & CDISC Expert

Puma Biotechnology Inc; United States; Remote; USD 175,000 - 210,000; Full time

Job summary

Puma Biotechnology Inc. in the United States is seeking a Principal Statistical Programmer to collaborate with biostatisticians, programmers, CRAs, data managers and project teams to meet timelines for statistical data analysis and reporting.

This remote, full-time role requires expert CDISC (SDTM/ADaM) knowledge, strong SAS programming skills, and the ability to develop robust macros and scripts for study outputs, listings, and regulatory submissions.

Qualifications

• Bachelor's degree in a Computer Science, Mathematics, Statistics or a quantitative/ analytical field.
• Minimum of 12 years of clinical trial programming experience in biotech/pharma CRO industry.
• Thorough understanding of clinical trials design and reporting process including regulatory submissions and CDISC implementation.
• Basic knowledge of coding dictionaries - MedDRA and WHODRUG.

Responsibilities

• Generates or oversees production of statistical output (tables, listings) for study reports and integrated summaries.
• Ensures programming and documentation align with departmental procedures.
• Leads development of robust SAS macros to generate outputs and CDISC implementations.
• Contributes to SAS Programming Work Instructions and Standards.
• Oversees or generates clinical listings for data checking and quality review.
• Develops techniques with Python, R, JS to enhance data analysis or visualization.
• Produces ad-hoc data or statistical output for regulatory, partner, or commercial needs.

Skills

SAS programming

SAS macros

Python

R

JavaScript

CDISC SDTM/ADaM

Oncology CDISC expertise

Education

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

Tools

MedDRA

WHODRUG

Job description

Puma Biotechnology Inc. in the United States is seeking a Principal Statistical Programmer to collaborate with biostatisticians, programmers, CRAs, data managers and project teams to meet timelines for statistical data analysis and reporting.

This remote, full-time role requires expert CDISC (SDTM/ADaM) knowledge, strong SAS programming skills, and the ability to develop robust macros and scripts for study outputs, listings, and regulatory submissions.