Senior Statistical Programmer, FSP – Remote

Cytel; Hagåtña (GU); Remote; USD 140,000 - 190,000; Full time

Job summary

Cytel’s sponsor-dedicated Principal Statistical Programmer will work within a global pharmaceutical client, driving SDTM/ADaM implementation and reporting. You’ll lead SAS-based programming, deliver complex listings and graphs, and supervise CRO work to ensure high-quality outputs for regulatory submissions.

You will apply GCP and FDA guidelines, contribute to standards, and collaborate across internal/external teams to meet study timelines.

Qualifications

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

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer’s guides, and define.xml for multiple studies
• Develop SAS programs for datasets, listings, tables, and graphs with descriptive/inferential stats
• Deliver high-quality SAS/R programs tailored to clinical development needs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, and DSURs
• Follow FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit checks, and data validation plans
• Provide data transfer specifications for external vendors
• Collaborate with CROs, vendors, and partners to meet timelines
• Draft SOPs and work instructions for statistical programming practices

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Communication

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel’s sponsor-dedicated Principal Statistical Programmer will work within a global pharmaceutical client, driving SDTM/ADaM implementation and reporting. You’ll lead SAS-based programming, deliver complex listings and graphs, and supervise CRO work to ensure high-quality outputs for regulatory submissions.

You will apply GCP and FDA guidelines, contribute to standards, and collaborate across internal/external teams to meet study timelines.