Principal Statistical Programmer – SDTM/ADaM Lead

Cytel; Santa Fe (NM); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, providing expert SAS programming and leadership for SDTM/ADaM data submissions. You will operate with minimal supervision, driving technical solutions and directing project work within cross-functional teams.

You will ensure compliance with FDA/ICH regulations, contribute to regulatory submissions, and mentor other programmers while maintaining rigorous documentation and quality standards.

Qualifications

• MS in biostatistics or related field with 8+ years in pharma
• BS in biostatistics or related field with 10+ years in pharma
• Expert in SAS language, procedures, and options used in clinical trial reporting

Responsibilities

• Provides technical and project management leadership in SAS programs and applications for complex trial data
• Creates, reviews and approves documentation to support data analysis and CDISC submission
• Leads compliance with SOPs and FDA/ICH/GCP regulations
• Participates in technical meetings with internal/external stakeholders (IS, CROs, Vendors, FDA/EMA)
• Performs QC of advanced SAS code and outputs
• Reviews Define.xml and creates reviewers guides for SDTM/ADaM datasets
• Maintains study documents per standard process
• Programs, tests and documents global utility programs and tools

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Communication

Education

MS in biostatistics

BS in biostatistics

Tools

SAS

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, providing expert SAS programming and leadership for SDTM/ADaM data submissions. You will operate with minimal supervision, driving technical solutions and directing project work within cross-functional teams.

You will ensure compliance with FDA/ICH regulations, contribute to regulatory submissions, and mentor other programmers while maintaining rigorous documentation and quality standards.