Senior SAS Statistical Programmer — Clinical Trials Lead

Cytel; Richmond (VA); On-site; USD 110,000 - 160,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client in the United States. You will lead SAS programming for complex clinical trial analyses and support SDTM/ADaM data submissions with minimal supervision.

Strong communication and leadership are essential as you coordinate with internal teams and external partners. The role requires extensive experience in regulatory submissions, Define.xml review, and a deep understanding of FDA/ICH guidelines.

Qualifications

• MS or BS in biostatistics or related field with pharmaceutical industry experience
• Exceptional SAS programming skills and clinical trial data analysis
• Extensive CDISC SDTM/ADaM experience and Define.xml
• Proven expert in SAS language, procedures, and macro language
• Experience with regulatory submissions and FDA/ICH interaction

Responsibilities

• Lead SAS programming for complex clinical trial analyses (Tables, Listings, Figures)
• Develop and review documentation for data analyses and CDISC submissions
• Ensure compliance with SOPs and regulatory requirements
• Brief management on progress and issues in projects
• Review and validate SDTM/ADaM datasets and Define.xml
• Provide technical leadership and mentorship to team members
• Coordinate with CROs, vendors, and regulatory authorities

Skills

SAS programming

CDISC (SDTM/ADaM)

Regulatory submissions

Project leadership

FDA/ICH knowledge

Biostatistics

Communication skills

Education

MS in Biostatistics

BS in Biostatistics

Tools

SAS

SAS/STAT

SAS/GRAPH

Define.xml review

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client in the United States. You will lead SAS programming for complex clinical trial analyses and support SDTM/ADaM data submissions with minimal supervision.

Strong communication and leadership are essential as you coordinate with internal teams and external partners. The role requires extensive experience in regulatory submissions, Define.xml review, and a deep understanding of FDA/ICH guidelines.