Senior / Principal Statistical Programmer (SAS) 7+ Years

Job Title: Senior Statistical Programmer (SAS) 7+ Years

Job Title: Principal Statistical Programmer (SAS) 9+ Years

Job Overview

We are looking for a Senior / Principal Statistical Programmer with strong SAS programming experience to support clinical trials (Phase 2/3 preferred). The role involves data extraction, SDTM/ADaM programming, and TLG development, ensuring high-quality, submission-ready deliverables aligned with industry standards.

Key Responsibilities

• Create and maintain SAS programs to support clinical trial analysis and reporting
• Develop analysis datasets for trial level reporting and integrated safety/efficacy activities
• Program and QC Tables, Listings & Graphs (TLGs) as defined in SAP
• Develop reusable utility macros to build a macro library supporting TLGs
• Collaborate with project teams to ensure timely and quality deliverables
• Create submission-ready datasets and outputs following SDLC & industry standards
• Maintain project documentation as per SOPs and processes
• Ensure compliance with industry quality standards, guidelines, and procedures
• Other duties as assigned

Required Skills & Experience

• 79+ years in Pharma/Biotech/CRO or relevant consulting experience
• Strong in Base SAS, Proc SQL, Macro programming, ODS
• Strong experience with CDISC standards: SDTM & ADaM
• Experience in clinical trial phases 14 (Phase 2/3 preferred)
• TLG programming, QC/validation as per SAP
• Knowledge of ICH/GCP, 21 CFR Part 11
• Knowledge of coding dictionaries: MedDRA, WHO, ICD-9, COSTART
• Strong communication, multitasking, and documentation skills

Good to Have

• NDA submission experience
• Pooled data analysis experience
• SAS modules: SAS/STAT, SAS/GRAPH, SAS/Connect, SAS/Access
• Shell/batch scripting exposure

Education

• Bachelors in Science / Computer Science / related field (Masters preferred)