Senior Statistical Programmer — Clinical Trials & Submissions

Cytel; Springfield (IL); Remote; USD 130,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work fully embedded with a sponsor client, delivering SDTM/ADaM, datasets, and reports while ensuring regulatory readiness.

You will lead SAS programming across studies, oversee CRO deliverables, and contribute to study reports and regulatory submissions, requiring 7+ years in biostatistics programming and strong independent work and leadership.

Qualifications

• Bachelor degree in computer science, data science, mathematics or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma development biometrics.
• Exceptional SAS programming skills and experience with statistical programming procedures in a clinical setting.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and regulatory knowledge.
• Experience supporting regulatory submissions and engaging with FDA or global authorities.
• Ability to work independently and lead effectively.
• Excellent written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs tailored to development programs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs and analyses.
• Understand FDA regulations affecting reporting of trial data.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project timelines and goals.
• Review/author SOPs and Work Instructions for statistical programming practices.

Skills

SAS programming

Independent work

Leadership

Communication

Education

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

Tools

CDISC standards (SDTM/ADaM)

Define.xml

SAS

R

Python

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work fully embedded with a sponsor client, delivering SDTM/ADaM, datasets, and reports while ensuring regulatory readiness.

You will lead SAS programming across studies, oversee CRO deliverables, and contribute to study reports and regulatory submissions, requiring 7+ years in biostatistics programming and strong independent work and leadership.