Clinical SAS / Statistical Programmer (ADaM | TLF | CDISC)

Clinical SAS / Statistical Programmer Experience: 515 Years Location: PAN India / Hybrid / Remote We are seeking professionals with hands-on experience delivering end-to-end statistical programming across the clinical trial lifecycle. The ideal candidate should have independently contributed to ADaM development, Safety & Efficacy TLF programming, SAP implementation, validation, and regulatory submission deliverables . Key Responsibilities Review clinical study documents including Protocols, Statistical Analysis Plans (SAPs), Annotated CRFs and Mock Shells. Develop and validate ADaM datasets in accordance with CDISC standards. Independently program and validate Safety & Efficacy Tables, Listings & Figures (TLFs). Implement Statistical Analysis Plans (SAPs) using SAS and/or R. Perform Quality Control (QC) and validation of statistical programming deliverables. Develop and maintain programming documentation including Define.xml, ADRG and validation documentation. Collaborate closely with Biostatisticians to deliver high-quality statistical outputs. Support cross-study and integrated analyses where applicable. Develop and maintain reusable SAS macros, utilities and programming standards. Support regulatory submissions, audits and inspections. Mentor junior programmers and contribute to continuous process improvement. Mandatory Skills Advanced SAS Programming ADaM Programming Safety & Efficacy TLF Programming Statistical Analysis Plan (SAP) Implementation CDISC Standards (SDTM & ADaM) Validation & Quality Control Define.xml, ADRG & Reviewer Guides Strong understanding of the clinical trial lifecycle and drug development process Experience collaborating directly with Biostatisticians Preferred Skills R Programming Cross-study / Integrated Data Analysis Programming Macro Development Oncology, Immunology, Neuroscience or other complex therapeutic area experience Experience supporting FDA, EMA or other global regulatory submissions .