Statistical Programmer

Astek; Ernakulam; On-site; INR 800,000 - 1,300,000; Full time

Job summary

Astek in India seeks a clinical data programmer to develop and validate ADaM datasets and TLFs for oncology trials. You will ensure regulatory-compliant deliverables and collaborate with statisticians, data managers, and clinical teams.

Role involves supporting ISS/ISE activities, contributing to dataset integration and documentation, and participating in agile processes. Proficiency in R and SAS in a biostatistics setting is required.

Qualifications

• Proficient in R programming; intermediate to advanced learning willingness.
• Solid experience in SAS programming in clinical/biostatistics.
• Hands-on ADaM dataset development and TLF programming experience.
• Good understanding of CDISC standards and clinical data flow.
• Strong problem-solving, detail-oriented, and able to work with cross-functional teams.

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.]
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Skills

R programming

SAS programming

ADaM dataset development

TLF programming

CDISC standards

Cross-functional collaboration

Problem-solving

Job description

• 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