Senior Statistical Programmer – Sponsor-Embedded FSP

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

Job summary

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor project, delivering SDTM/ADaM specifications, datasets and define.xmls. You will develop SAS programs for complex listings, tables and graphs and ensure high-quality outputs across studies.

You will oversee CRO deliverables, support CSR submissions, DSURs and exploratory analyses, and contribute to programming standards. Strong independence and leadership are essential.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics (preferred)
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics
• Exceptional SAS programming skills for clinical development
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH guidelines
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently with strong leadership and communication skills

Responsibilities

• Generate SDTM/ADaM specs, datasets, reviewer’s guide and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables and graphs
• Deliver high-quality SAS/R programming outputs for clinical development programs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of CSRs, regulatory submissions, publications and DSURs
• Develop and maintain programming standards, templates and validation plans
• Contribute to CRFs, edit checks, data validation plans, data transfers with vendors
• Collaborate with CROs, software vendors and clinical partners to meet project goals
• Prepare SOPs and work instructions related to statistical programming practices
• Excellent written and verbal communication skills

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Education

Bachelor’s degree (computer science, data science, mathematics, or statistics)

Tools

R

Python

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor project, delivering SDTM/ADaM specifications, datasets and define.xmls. You will develop SAS programs for complex listings, tables and graphs and ensure high-quality outputs across studies.

You will oversee CRO deliverables, support CSR submissions, DSURs and exploratory analyses, and contribute to programming standards. Strong independence and leadership are essential.