Statistical Programmer

Astek; Ernakulam; Presencial; INR 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Astek India seeks an experienced clinical programmer to develop, validate, and maintain ADaM datasets, TLFs, and other analytical outputs for clinical trials. You will support Oncology studies, ensuring accuracy, consistency, and regulatory compliance, and contribute to ISS/ISE activities.

Join a cross-functional team and collaborate with statisticians, data managers, and clinical teams to ensure timely and quality delivery while participating in an agile environment and using GSK tools and

Formación

• Proficiency in R programming.
• Solid experience in SAS programming 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 cross-functional collaboration.

Responsabilidades

• Develop, validate, and maintain ADaM datasets, TLFs, and analytical outputs for clinical trials.
• Support Oncology studies, ensuring accuracy, consistency, and regulatory compliance.
• Contribute to ISS/ISE activities, including dataset integration, analysis, and documentation.
• Collaborate with statisticians, data managers, and clinical teams to ensure timely delivery.
• Assist in regulatory submissions and RTQs, providing traceable programming outputs.
• Work in an agile environment, participating in sprint meetings and continuous improvement.
• Engage with internal tools, including GSK-specific platforms, following governance standards.
• Troubleshoot data/programming issues and propose process enhancements; ensure audit-ready documentation.

Conocimientos

R programming

SAS programming

ADaM dataset development

TLF programming

CDISC standards

Cross-functional collaboration

GSK tools

Herramientas

GSK tools

Descripción del empleo

• 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