Autonomous Principal Statistical Programmer – Global Clinical Trials

Cytel; Salem (OR); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, driving complex data analysis and SDTM/ADaM submissions. You will lead programming efforts, ensure regulatory compliance, and contribute to study-level documents.

Ideal candidates have 8+ years in pharma with expert SAS skills and CDISC experience, plus strong leadership and communication abilities to coordinate with cross-functional teams.

Qualifications

• MS in biostatistics or a related field with 8+ years pharma experience, or BS with 10+ years.
• Exceptional SAS programming skills for clinical data analysis and reporting.
• Experience with CDISC standards (SDTM/ADaM) and Define.xml.
• Regulatory submission experience with FDA/ICH guidance is a plus.
• Ability to lead project teams and communicate complex technical solutions.

Responsibilities

• Lead SAS programs for tables, listings, and figures for complex trials.
• Develop and review documentation to support data analysis and CDISC submissions.
• Ensure compliance with SOPs and regulatory standards.
• Present progress and issues to management and stakeholders.
• Mentor junior programmers and lead project sub-teams.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Leadership

Excellent communication

Education

MS in biostatistics or related field

BS in biostatistics or related field

Tools

SAS

SAS Macro language

SAS/STAT

SAS/GRAPH

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, driving complex data analysis and SDTM/ADaM submissions. You will lead programming efforts, ensure regulatory compliance, and contribute to study-level documents.

Ideal candidates have 8+ years in pharma with expert SAS skills and CDISC experience, plus strong leadership and communication abilities to coordinate with cross-functional teams.