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 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