Senior Statistical Programmer — Lead Global Clinical Data

Cytel; Frankfort (KY); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel Inc. is seeking a Principal Statistical Programmer embedded with a pharmaceutical client. You will lead the development and validation of SDTM/ADaM datasets, reviewer’s guides, and define.xml, ensuring compliance with FDA regulations.

You will deliver SAS/R programs for complex listings, tables, and graphs, oversee deliverables across studies, and collaborate with CROs and internal teams to meet timelines and quality standards.

Qualifications

• Bachelor's degree in CS, data science, math, or stats.
• 9+ years as a statistical programmer in Biotech/Pharma.
• Expert SAS/R programming for clinical development.
• Extensive CDISC SDTM/ADaM/Define.xml experience.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently with strong leadership.
• Strong verbal and written communication.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml for studies.
• Lead SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results for clinical programs.
• Support clinical study reports and regulatory submissions.
• Collaborate with CROs and vendors to meet timelines.

Skills

SAS programming

R programming

Leadership

Independent worker

Communication

Education

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

Tools

SAS

R

Python

Java

Unix/Linux

Git

Shiny

Markdown

Job description

Cytel Inc. is seeking a Principal Statistical Programmer embedded with a pharmaceutical client. You will lead the development and validation of SDTM/ADaM datasets, reviewer’s guides, and define.xml, ensuring compliance with FDA regulations.

You will deliver SAS/R programs for complex listings, tables, and graphs, oversee deliverables across studies, and collaborate with CROs and internal teams to meet timelines and quality standards.