Lead Statistical Programmer - Clinical Data & Submissions

Cytel; Denver (CO); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer who will work embedded with a pharmaceutical client, providing expert SAS/R programming leadership across SDTM/ADaM data sets and regulatory submissions. You will mentor colleagues, ensure data package quality, and drive standards while collaborating with CROs and internal teams.

The role requires 9+ years’ experience in biotech/pharma biometrics, deep CDISC knowledge, and ability to work independently under FDA-regulated timelines.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 9+ years of experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS/R programming skills and expertise in clinical development environment
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and interaction with FDA/global authorities
• Ability to deliver under tight timelines while adopting new technologies and standards
• Ability to work independently and communicate effectively with leadership and cross-functional teams

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to generate datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results and validate SAS/R programs for clinical development
• Oversee programming deliverables for multiple studies to meet timelines
• Support preparation of clinical study reports, regulatory submissions and exploratory analyses
• Create, maintain, and validate standards for programming tools, outputs and macros
• Collaborate with CROs, vendors and internal teams to meet project goals

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

FDA regulatory submissions

Leadership

Independent work

Education

Bachelor's degree in Computer Science, Statistics, or related field

Tools

SAS

R

Job description

Cytel is seeking a Principal Statistical Programmer who will work embedded with a pharmaceutical client, providing expert SAS/R programming leadership across SDTM/ADaM data sets and regulatory submissions. You will mentor colleagues, ensure data package quality, and drive standards while collaborating with CROs and internal teams.

The role requires 9+ years’ experience in biotech/pharma biometrics, deep CDISC knowledge, and ability to work independently under FDA-regulated timelines.