Principal Statistical Programmer: SDTM/ADaM Lead for Submissions

Cytel; Honolulu (HI); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer in the United States, embedding with one of our pharmaceutical clients. You will lead SAS-based analyses for SDTM/ADaM submissions, influence program direction, and mentor team members.

The role requires expert SAS skills, CDISC standards mastery, and strong communication and leadership capabilities to drive regulatory submissions and cross-functional collaboration.

Qualifications

• MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry
• Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures in a clinical development environment
• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
• Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH

Responsibilities

• Provides technical and project management leadership in SAS programs and applications for complex clinical trial data
• Creates, reviews, and approves documentation to support data analysis and CDISC data submission
• Ensures compliance with SOPs and FDA/ICH regulations
• Leads technical meetings with internal and external stakeholders
• Performs quality control of advanced SAS code and reviews Define.xml and reviewers guides
• Develops and documents global utility programs and tools
• Performs other duties as assigned

Skills

SAS programming

CDISC standards

Leadership

Communication

Independent work

Education

MS in Biostatistics

BS in Biostatistics

Tools

BASE SAS

SAS/STAT

SAS/GRAPH

SAS Macro Language

Job description

Cytel is seeking a Principal Statistical Programmer in the United States, embedding with one of our pharmaceutical clients. You will lead SAS-based analyses for SDTM/ADaM submissions, influence program direction, and mentor team members.

The role requires expert SAS skills, CDISC standards mastery, and strong communication and leadership capabilities to drive regulatory submissions and cross-functional collaboration.