Senior Statistical Programmer - Clinical Data & Submissions

Cytel; Lincoln (NE); On-site; USD 140,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer dedicated to a pharmaceutical client. You will lead statistical programming activities across studies, develop SDTM/ADaM datasets, and ensure high-quality, compliant deliverables.

The role emphasizes independent work, client collaboration, and leadership in a dynamic environment. The position requires 9+ years in biotech/pharma programming, strong SAS/R expertise, and experience with FDA submissions.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 9+ years of experience as Statistical Programmer in Biotech/Pharma or similar.
• Exceptional SAS/R programming skills and experience with clinical programming procedures.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interacting with FDA or global authorities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Lead and support development of SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality programming results and maintain SAS and/or R programs.
• Oversee programming deliverables across studies to meet timelines.
• Prepare clinical study reports, regulatory submissions, publications, and analyses.

Skills

SAS programming

R programming

Leadership

Communication

Independent work

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Cytel is seeking a Principal Statistical Programmer dedicated to a pharmaceutical client. You will lead statistical programming activities across studies, develop SDTM/ADaM datasets, and ensure high-quality, compliant deliverables.

The role emphasizes independent work, client collaboration, and leadership in a dynamic environment. The position requires 9+ years in biotech/pharma programming, strong SAS/R expertise, and experience with FDA submissions.