Senior Principal Statistical Programmer - SAS & CDISC Lead

Cytel; Augusta (ME); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel, a leader in statistical programming, is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client. You will lead SAS programming efforts for complex trials and will own CDISC SDTM/ADaM submissions with minimal supervision.

You will review documentation, ensure regulatory compliance, and communicate progress to management as a project lead. Strong leadership and written/verbal communication are essential.

Qualifications

• MS with 8+ years of pharma industry experience or BS with 10+ years.
• Exceptional SAS programming skills in clinical development.
• Extensive CDISC SDTM/ADaM/Define.xml experience.
• Proven SAS language proficiency and related tools.
• Regulatory submission experience with FDA/ICH.
• Ability to work independently and lead teams.

Responsibilities

• Provide technical and project management leadership in SAS programs for complex trial data.
• Create, review, and approve documentation for data analysis and CDISC submissions.
• Ensure compliance with SOPs and FDA/ICH/GCP regulations.
• Lead technical meetings with internal and external stakeholders.
• Perform QC checks of advanced SAS code and outputs.
• Review Define.xml and prepare reviewers guides for SDTM/ADaM.
• Maintain study documents per standard processes.
• Develop, test, and document global utility programs.

Skills

SAS programming

Clinical programming leadership

Independent work capability

Strong communication

Regulatory submission experience

Education

MS in biostatistics or related field

BS in biostatistics or related field

Tools

SAS (BASE SAS, SAS/STAT, SAS/GRAPH)

SAS Macro language

Job description

Cytel, a leader in statistical programming, is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client. You will lead SAS programming efforts for complex trials and will own CDISC SDTM/ADaM submissions with minimal supervision.

You will review documentation, ensure regulatory compliance, and communicate progress to management as a project lead. Strong leadership and written/verbal communication are essential.