Senior Principal Statistical Programmer, FSP — Remote

Cytel; Little Rock (AR); Remote; USD 120,000 - 150,000; Full time

Job summary

Cytel Inc. is seeking a Principal Statistical Programmer to work embedded with a sponsor in the pharmaceutical industry in the United States. You will lead and execute statistical programming activities across studies, delivering SDTM/ADaM outputs and complex graphs with high quality.

You will mentor junior programmers, oversee CRO deliverables, and ensure compliance with FDA/ICH guidelines while driving data standards and efficient reporting in a fast-paced development environment.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in biotech/pharma or similar.
• Exceptional SAS programming skills and experience with CDISC standards.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer’s guides, and define.xml.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Adhere to FDA/ICH regulations and GCP for electronic submissions.
• Create and maintain standards for programming tools and macros.
• Collaborate with internal and external partners to meet milestones.

Skills

Leadership

Communication

Independence

CRO collaboration

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Principal Statistical Programmer to work embedded with a sponsor in the pharmaceutical industry in the United States. You will lead and execute statistical programming activities across studies, delivering SDTM/ADaM outputs and complex graphs with high quality.

You will mentor junior programmers, oversee CRO deliverables, and ensure compliance with FDA/ICH guidelines while driving data standards and efficient reporting in a fast-paced development environment.