Statistical Programmer (Ernakulam)

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 setting.
- 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 Apply on Kit Job: kitjob.in/job/4n6b2b