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
7–9+ years in Pharma / Biotech / CRO or relevant consulting experienceStrong in Base SAS, Proc SQL, Macro programming, ODSStrong experience with CDISC standards : SDTM & ADaMExperience in clinical trial phases 1–4 (Phase 2 / 3 preferred)TLG programming, QC / validation as per SAPKnowledge of ICH / GCP, 21 CFR Part 11Knowledge of coding dictionaries : MedDRA, WHO, ICD-9, COSTARTStrong communication, multitasking, and documentation skillsGood to Have
NDA submission experiencePooled data analysis experienceSAS modules : SAS / STAT, SAS / GRAPH, SAS / Connect, SAS / AccessShell / batch scripting exposureEducation
Bachelor’s in Science / Computer Science / related field (Master’s preferred)