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
- Bachelor's in Science / Computer Science / related field (Master's preferred)
