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

vueverse.; India; On-site; INR 1,400,000 - 3,000,000; Full time

Job summary

vueverse. seeks professionals with hands-on experience delivering end-to-end statistical programming across the clinical trial lifecycle.

The ideal candidate has contributed to ADaM development, safety and efficacy TLF programming, SAP implementation, validation, and regulatory submission deliverables. Responsibilities include reviewing protocols and SAPs, developing ADaM datasets, programming TLFs, implementing SAPs with SAS/R, and ensuring QC and validation of all outputs.

Qualifications

• Hands-on experience delivering end-to-end statistical programming across the clinical trial lifecycle.
• Independently contributed to ADaM development, Safety & Efficacy TLF programming, SAP implementation, validation, and regulatory submission deliverables.
• Strong understanding of CDISC SDTM & ADaM standards and Define.xml/ADRG documentation.

Responsibilities

• Review study documents including Protocols, SAPs, Annotated CRFs and Mock Shells.
• Develop and validate ADaM datasets in CDISC standards.
• Independently program and validate Safety & Efficacy TLFs.
• Implement SAPs using SAS and/or R.
• QC and validation of programming deliverables.
• Create and maintain Define.xml, ADRG and validation documentation.
• Collaborate with Biostatisticians to deliver high-quality outputs.
• Support cross-study analyses and regulatory submissions.
• Develop reusable SAS macros and standards.
• Mentor junior programmers and drive process improvements.

Skills

Advanced SAS Programming

ADaM Programming

SAP Implementation

CDISC SDTM & ADaM

Validation & Quality Control

Define.xml, ADRG & Reviewer Guides

Collaboration with Biostatisticians

Tools

SAS

R

Job description

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
• 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
• Oncology, Immunology, Neuroscience or other complex therapeutic area experience
• Experience supporting FDA, EMA or other global regulatory submissions