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
or continue with email
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
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