Senior Statistical Programmer, Sponsor-FSP, Remote

Cytel; Austin (TX); Remote; USD 130,000 - 170,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor in the pharmaceutical industry. You will work independently with minimal supervision on clinical development programs, leading SAS/R-based programming and overseeing CRO deliverables to ensure high-quality data summaries and compliant submissions.

You will implement SDTM/ADaM specifications, develop complex listings and graphs, and support regulatory submissions while adhering to FDA/ICH guidelines.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics is preferred.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma projects or similar.
• Exceptional SAS programming skills and ability to develop statistical programming procedures.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and regulatory submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality programming results and validate SAS/R programs for clinical programs.
• Oversee CRO deliverables to meet timelines and quality standards.
• Contribute to study reports, regulatory submissions, and exploratory analyses.

Skills

Independent work

Communication

Leadership

Education

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor in the pharmaceutical industry. You will work independently with minimal supervision on clinical development programs, leading SAS/R-based programming and overseeing CRO deliverables to ensure high-quality data summaries and compliant submissions.

You will implement SDTM/ADaM specifications, develop complex listings and graphs, and support regulatory submissions while adhering to FDA/ICH guidelines.