Principal Statistical Programmer: CDISC Lead for Submissions

Cytel; Carson City (NV); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor project. You will lead SAS programming for complex clinical trial data, including SDTM/ADaM, Define.xml, and regulatory submissions, with minimal supervision and strong cross-functional collaboration.

You will provide technical leadership, ensure SOP and FDA/ICH/GCP compliance, and interface with external partners to deliver high-quality analytics and reports.

Qualifications

• MS or BS in biostatistics or related field with pharmaceutical industry experience
• Exceptional SAS programming skills for clinical trial data analysis and reporting
• Extensive experience with CDISC SDTM/ADaM and Define.xml
• Proven expertise in SAS language and procedures for clinical reporting
• Experience supporting regulatory submissions to FDA/ICH
• Ability to work independently and lead sub-teams
• Strong written and oral communication, with cross-functional influence
• Experience with BLAs/MAAs is a plus

Responsibilities

• Lead SAS programs for tables, listings and figures and SDTM/ADaM submissions
• Review and approve documentation supporting data analysis and CDISC submissions
• Ensure compliance with SOPs and FDA/ICH/GCP regulations
• Lead technical meetings with internal/external stakeholders
• Perform QC on advanced SAS code and outputs
• Develop and validate global utility programs and tools
• Prepare Define.xml and reviewers guides for datasets
• Assist with project planning and study-level documentation

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Project leadership

Communication skills

FDA/ICH/GCP regulations

Independent work

SAS Macro language

SAS/GRAPH

SAS/STAT

Education

MS in biostatistics

BS in biostatistics

Tools

SAS/GRAPH

SAS/STAT

BASE SAS

Job description

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor project. You will lead SAS programming for complex clinical trial data, including SDTM/ADaM, Define.xml, and regulatory submissions, with minimal supervision and strong cross-functional collaboration.

You will provide technical leadership, ensure SOP and FDA/ICH/GCP compliance, and interface with external partners to deliver high-quality analytics and reports.