Senior Statistical Programmer - Lead SDTM/ADaM Submissions

Cytel; Frankfort (KY); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

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Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality SDTM/ADaM outputs and leading programming efforts. You will independently manage projects, supervise others, and ensure timely delivery across multicenter studies in a fast-paced environment.

The role emphasizes SAS/R expertise, CDISC standards, and collaboration with CROs and regulatory teams to support submissions and publications.

Qualifications

• Bachelor’s degree in CS/Data Science/Math/Statistics.
• 9+ years of statistical programming in pharma/biotech.
• Expert SAS/R programming in clinical development.
• CDISC SDTM/ADaM/Define.xml experience.
• Experience with FDA submissions.
• Independent worker with strong leadership.
• Excellent written and verbal communication.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for multiple studies.
• Lead SAS/R programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality programming results and maintain standards.
• Support preparing regulatory submissions and clinical study reports.
• Collaborate with CROs and vendors to meet project timelines and goals.
• Develop/validate standards for programming tools and macros.
• Review data transfer specifications for external data.
• Provide expert technical guidance to junior programmers.

Skills

9+ years statistical programming

Independence

Leadership

Communication

Adaptability

Regulatory submissions

FDA interactions

Clinical development

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

SAS

R

CDISC (SDTM/ADaM/Define.xml)

Python

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality SDTM/ADaM outputs and leading programming efforts. You will independently manage projects, supervise others, and ensure timely delivery across multicenter studies in a fast-paced environment.

The role emphasizes SAS/R expertise, CDISC standards, and collaboration with CROs and regulatory teams to support submissions and publications.