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 transparent, traceable, and compliant programming outputs.
Collaborate in an
agile workplace
, 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, valuable 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 workplace.
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 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 Kochi
🏢 Astek
📍 Kochi