Key ResponsibilitiesDevelop, validate, and maintain

ADaM datasets ,

TLFs , and other analytical outputs for clinical trials.Support

Oncology studies

by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables.Contribute to

ISS/ISE activities , including dataset integration, analysis, and documentation.Work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery.Assist in

regulatory submissions

and

RTQs , providing explicit, traceable, and compliant programming outputs.Collaborate in an

agile environment , participating in sprint meetings, planning, and continuous improvement discussions.Work with internal tools and platforms, including

GSK-specific tools , following established standards and governance.Troubleshoot data/programming issues and propose process enhancements.Ensure adherence to CDISC standards, good programming practices,



and audit-ready documentation.Required Skills & QualificationsProficiency in R programming(Intermediate candidates with strong learning intent and ability to upskill quickly will also be considered.)Solid experience in

SAS programming , especially in a clinical/biostatistics environment.Hands-on expertise in

ADaM dataset development

and

TLF programming .Good understanding of

CDISC standards

and clinical trial data flow.Strong problem-solving skills, attention to detail, and ability to work in cross-functional teams.Preferred QualificationsAdvanced or Expert-level R Programming

skills.Experience working on

Oncology therapeutic area

studies.Exposure to

ISS/ISE , submission workflows, and regulatory interactions (e.g., RTQs).Practical understanding of

agile ways of working

(Scrum/Kanban).Prior experience using or supporting

GSK tools and platforms

📌 Statistical Programmer (Mumbai)
🏢 Astek
📍 Mumbai