Statistical Programmer

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.