Senior SAS Programmer Lead - Clinical Trials (SDTM/ADaM)

Cytel; Juneau (AK); On-site; USD 160,000 - 210,000; Full time

Job summary

Cytel is sponsoring a Principal Statistical Programmer embedded with a global pharmaceutical client. You will lead SAS programming efforts for complex clinical trials, ensure SDTM/ADaM compliance and prepare submission-ready datasets.

You will mentor teammates, interact with external partners, and drive regulatory submissions. Requires 8+ years in pharma, deep SAS, CDISC expertise, and strong communication.

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 for clinical trials
• Extensive CDISC (SDTM/ADaM/Define.xml) experience
• Proven expert in SAS language, procedures, and options used in clinical reporting
• Experience supporting regulatory submissions with FDA/global authorities
• Ability to work independently
• Strong written and verbal communication and leadership abilities

Responsibilities

• Provide technical and project management leadership in SAS for complex clinical trial data
• Create, review, and approve documentation to support data analysis and CDIS submission
• Ensure compliance with SOPs and FDA/ICH regulations
• Lead technical meetings with internal/external stakeholders (IS, CROs, vendors, FDA/EMA)
• Perform quality control on SAS code and datasets
• Review Define.xml and prepare reviewers guides for SDTM/ADaM
• Maintain study documents per standard processes
• Program, test, and document global utilities and tools

Skills

SAS programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions

Independent work

Written and verbal communication

Leadership

FDA/ICH familiarity

SAS macro language

Education

MS in Biostatistics

BS in Biostatistics

Job description

Cytel is sponsoring a Principal Statistical Programmer embedded with a global pharmaceutical client. You will lead SAS programming efforts for complex clinical trials, ensure SDTM/ADaM compliance and prepare submission-ready datasets.

You will mentor teammates, interact with external partners, and drive regulatory submissions. Requires 8+ years in pharma, deep SAS, CDISC expertise, and strong communication.