Senior Statistical Programmer - FSP (Remote)

Cytel; Carson City (NV); Remote; USD 120,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a sponsor client, driving data analysis and reporting for clinical trials. You will develop SDTM/ADaM specifications, create complex listings and graphs, and oversee CRO programmers to ensure high-quality deliverables in a fast-paced environment.

You will contribute to regulatory submissions and study reports, while adhering to FDA/ICH guidelines. A strong SAS skill set and leadership ability are essential for success.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Strong SAS programming skills and CDISC (SDTM/ADaM/Define.xml) expertise.
• Experience with regulatory submissions and FDA/ICH guidelines.
• Ability to work independently and lead CRO programming efforts.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer’s guide, and define.xml.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming outputs for clinical studies.
• Oversee CRO programming deliverables to meet timelines.
• Support clinical study reports, regulatory submissions, and DSURs.
• Create and maintain programming standards and SOPs.

Skills

SAS programming

Statistical programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication

Education

Bachelor’s degree in computer science / data science / mathematics / statistics

Tools

R

Python

Java

Unix/Linux

Git

Shiny

Markdown

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a sponsor client, driving data analysis and reporting for clinical trials. You will develop SDTM/ADaM specifications, create complex listings and graphs, and oversee CRO programmers to ensure high-quality deliverables in a fast-paced environment.

You will contribute to regulatory submissions and study reports, while adhering to FDA/ICH guidelines. A strong SAS skill set and leadership ability are essential for success.