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
- Solid 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
📌 Clinical SAS / Statistical Programmer (ADaM | TLF | CDISC) (India)
🏢 vueverse.
📍 India
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