Statistical Programmer

Location: Kochi H.O

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.
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