Lead Statistical Programmer - Clinical Data & Submissions

Cytel; Madison (WI); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality programming for clinical development programs. You will lead SAS/R programming efforts, develop SDTM/ADaM outputs, and supervise study-level programming with minimal supervision.

The role emphasizes independent work, leadership, and collaboration with CROs and vendors to meet regulatory timelines and ensure robust data for submissions and publications.

Qualifications

• Bachelor's degree in CS, data science, mathematics, or statistics.
• 9+ years of statistical programming experience in Biotech/Pharma.
• Strong SAS and R programming skills.
• Extensive CDISC SDTM/ADaM/Define.xml experience.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently and lead teams.
• Excellent written and verbal communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Follow FDA regulations affecting reporting of clinical trial data and support multiple FDA submissions
• Lead and support the development of SAS programs to generate datasets, complex listings, tables, and complex graphs
• Deliver high-quality statistical programming results with SAS and/or R programs tailored to clinical development needs
• Oversee programming deliverables for multiple clinical studies to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Provide review/author data transfer specifications for external vendor data
• Collaborate with CROs, software vendors, and clinical development partners to meet timelines and goals

Skills

Leadership

Communication

Independent work

Education

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

Tools

SAS

R

Define.xml

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality programming for clinical development programs. You will lead SAS/R programming efforts, develop SDTM/ADaM outputs, and supervise study-level programming with minimal supervision.

The role emphasizes independent work, leadership, and collaboration with CROs and vendors to meet regulatory timelines and ensure robust data for submissions and publications.