Key Responsibilities
Develop, 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 clear, 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 & Qualifications




Proficiency 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.
Robust problem-solving skills, attention to detail, and ability to work in cross-functional teams.
Preferred Qualifications
Advanced 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