Principal Statistical Programmer – Lead CDISC Submissions

Cytel; Carson City (NV); On-site; USD 140,000 - 210,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to lead SAS programming for complex clinical trial analyses and regulatory submissions. You will work with SDTM/ADaM datasets, Define.xml documentation, and ensure compliance with FDA/ICH regulations.

The role requires independent work, strong communication, and leadership across cross-functional teams. You will interact with sponsors, CROs, and regulatory bodies to drive data analysis, reporting, and submission readiness.

Qualifications

• MS in biostatistics or related field with 8+ years in pharma.
• Exceptional SAS programming skills and CDISC (SDTM/ADaM).
• Experience with regulatory submissions (FDA/ICH) and Define.xml.
• Ability to work independently and lead projects.

Responsibilities

• Leads SAS programming for complex clinical trial analyses and submissions.
• Interfaces with CDISC SDTM/ADaM datasets and Create Define.xml documentation.
• Ensures compliance with SOPs and FDA/ICH regulations across programs.
• Represents the team in technical meetings with sponsors, CROs, and regulators.
• Performs QC on SAS code and reviews datasets and outputs.
• Develops global utility programs and validates them per standards.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Project leadership

Communication skills

Education

MS in biostatistics or related field

BS in biostatistics or related field

Tools

SAS

Define.xml tooling

Job description

Cytel is seeking a Principal Statistical Programmer to lead SAS programming for complex clinical trial analyses and regulatory submissions. You will work with SDTM/ADaM datasets, Define.xml documentation, and ensure compliance with FDA/ICH regulations.

The role requires independent work, strong communication, and leadership across cross-functional teams. You will interact with sponsors, CROs, and regulatory bodies to drive data analysis, reporting, and submission readiness.