Job Description
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
5-14 years of Industrial experience
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.
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 .
Why Join Us?
Opportunity to work on impactful
Oncology research
with global teams
Continuous learning and upskilling environment
Collaborative, agile work culture
Exposure to end-to-end statistical programming lifecycle and regulatory submissions
Ready to Apply?
Don't miss this opportunity! Apply now and join our team.
Job Details
Posted Date:
February 27, 2026
Job Type:
Arts and Entertainment
Location:
India
Company:
Simelabs - Digital, AI/ML, Automation, Robotics, Gen AI.
Ready to Apply?
Don't miss this opportunity! Apply now and join our team.