Principal Statistical Programmer FSP

Overview

In this Senior Statistical Programmer role, you’ll support or lead one or more clinical trials for a global pharmaceutical client, applying advanced SAS programming and CDISC SDTM/ADaM standards. You’ll work within a cross-functional Cytel-enabled team to produce high-quality data manipulation, analyses, and submission-ready outputs. The position offers remote work and emphasizes rigorous data standards, validation, and timely deliverables. You’ll play a key part in shaping data-driven decision making for patient-focused therapies and complex clinical programs.

Responsibilities

• Data manipulation, analysis and reporting of clinical trial data (safety and efficacy) using SAS
• Produce and validate SDTM and ADaM datasets/analysis files, and TLFs
• QC/validation programming and complex ad-hoc reporting
• Create and review submission documents eCRTs and define.xml-related artifacts
• Lead duties when needed and coordinate with cross-functional teams
• Support immunology, respiratory or oncology studies when applicable
• Maintain adherence to timelines and ensure quality deliverables
• Communicate project specifications and issues with clients and internal teams

Key requirements

• 8+ years SAS programming with clinical trial data (Pharma/Biotech)
• 6+ years with Master’s degree or higher
• Strong data manipulation, analysis and reporting skills in SAS
• Solid experience with CDISC SDTM/ADaM standards
• QC/validation and ad-hoc reporting proficiency
• Experience with efficacy analyses and drug development lifecycle
• Submission document experience (define.xml and related artifacts)
• Ability to work in globally dispersed teams and meet challenging timelines
• Study lead experience preferred

• analytical mindset
• troubleshooting skills
• cross-functional collaboration
• SAS programming
• CDISC SDTM/ADaM
• Efficacy analysis

…