Lead Statistical Programmer – Clinical Data & Submissions

Cytel; Jackson (MS); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel embedded within a pharmaceutical client offers a Principal Statistical Programmer role focused on independent, high-quality programming leadership. You will guide study-level programming and foster long-term client relationships, delivering SDTM/ADaM outputs and defining XML standards across programs.

You will bring 9+ years in Biotech/Pharma Biometrics, with expert SAS/R skills, CDISC standards, and experience supporting regulatory submissions; teamwork and mentorship are essential in

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 9+ years as a Statistical Programmer in biotech/pharma development with leadership experience.
• Expert SAS/R programming and CDISC SDTM/ADaM/Define.xml knowledge.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently and mentor others.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, and define.xml for multiple studies.
• Lead SAS programs to produce listings, tables, and graphs for submissions.
• Ensure high-quality programming deliverables within timelines.
• Support regulatory submissions and clinical study reports.
• Collaborate with CROs and vendors to meet project goals.

Skills

SAS programming

R programming

CDISC standards

Leadership

FDA submissions

Education

Bachelor's degree in Computer Science/Data Science/Mathematics/Statistics

Tools

SAS

R

Python

Shiny

Unix/Linux

Git

Job description

Cytel embedded within a pharmaceutical client offers a Principal Statistical Programmer role focused on independent, high-quality programming leadership. You will guide study-level programming and foster long-term client relationships, delivering SDTM/ADaM outputs and defining XML standards across programs.

You will bring 9+ years in Biotech/Pharma Biometrics, with expert SAS/R skills, CDISC standards, and experience supporting regulatory submissions; teamwork and mentorship are essential in