Principal Statistical Programmer - Lead SDTM/ADaM

Cytel; San Juan (PR); On-site; USD 130,000 - 170,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer dedicated to a global pharmaceutical client. You will work independently, lead programming activities for SDTM/ADaM, and contribute to regulatory submissions while mentoring junior team members.

The role emphasizes high-quality data delivery, collaboration with CROs and vendors, and adopting new technologies within clinical development.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 9+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics teams.
• Exceptional SAS/R programming skills and regulatory submission experience.
• Extensive CDISC SDTM/ADaM experience and FDA/ICH regulation familiarity.
• Ability to work independently and lead while collaborating with vendors and CROs.
• Excellent written and verbal communication and leadership abilities.

Responsibilities

• Generate SDTM/ADaM datasets, reviewer’s guides, and define.xml for multiple studies.
• Lead SAS programming to produce tables, listings and figures; validate scripts.
• Ensure data delivery meets timelines and regulatory expectations.
• Support clinical study reports, regulatory submissions, and exploratory analyses.
• Develop and maintain programming standards and interact with vendors.

Skills

SAS programming

R programming

Leadership

Communication

CDISC SDTM/ADaM

FDA/ICH regulations

Education

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

Tools

SAS

R

Unix/Linux

Git

Define.xml

Job description

Cytel is seeking a Principal Statistical Programmer dedicated to a global pharmaceutical client. You will work independently, lead programming activities for SDTM/ADaM, and contribute to regulatory submissions while mentoring junior team members.

The role emphasizes high-quality data delivery, collaboration with CROs and vendors, and adopting new technologies within clinical development.