Principal Statistical Programmer – Clinical Trials Leader

Cytel; Boise (ID); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer who will dedicate to a global pharmaceutical client and lead complex SAS programming efforts for tables, listings and figures, as well as CDISC SDTM/ADaM submissions. The role requires independence, strong technical leadership, and the ability to communicate status and risks to management.

You will drive documentation, quality checks, and collaboration with CROs, FDA/EMA stakeholders, and internal teams to ensure successful regulatory

Qualifications

• MS in biostatistics or related field with 8+ years in pharma.
• BS in biostatistics or related field with 10+ years in pharma.
• Exceptional SAS programming skills in clinical development.
• Extensive experience with CDISC SDTM/ADaM/Define.xml.
• Regulatory submissions experience with FDA/global authorities.
• Ability to work independently.
• Strong written and oral communication and leadership.
• Experience with BLAs/MAAs is a plus.

Responsibilities

• Provides technical and project management leadership in SAS programs and applications for analysis and reporting in Tables, Listings, and Figures, plus CDlSC submissions with minimal supervision.
• Creates, reviews, and approves documentation to support data analysis and CDlSC data submission.
• Leads to ensure compliance with SOPs and FDA/ICH/GCP regulations.
• Conducts briefings and participates in technical meetings with internal and external representatives.
• Performs QA checks of advanced SAS code for datasets and outputs.
• Reviews Define.xml and creates reviewers guides for SDTM/ADaM datasets.
• Reviews and maintains study documents per standard processes.
• Programs, tests, and documents global utilities per standards and validation procedures.
• Performs other duties as assigned

Skills

SAS programming

CDISC standards

SAS language

Regulatory submissions

Independence

Presentation skills

Communication

Cross-functional influence

Regulatory submissions (BLAs/MAAs)

Education

MS in biostatistics or related field

BS in biostatistics or related field

Job description

Cytel is seeking a Principal Statistical Programmer who will dedicate to a global pharmaceutical client and lead complex SAS programming efforts for tables, listings and figures, as well as CDISC SDTM/ADaM submissions. The role requires independence, strong technical leadership, and the ability to communicate status and risks to management.

You will drive documentation, quality checks, and collaboration with CROs, FDA/EMA stakeholders, and internal teams to ensure successful regulatory