Statistical Programmer

Astek; Ernakulam; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Astek in India is seeking a skilled Clinical Data Programmer to join our biostatistics team. You will develop, validate, and maintain ADaM datasets, TLFs, and other analytical outputs for clinical trials, with a focus on Oncology studies.

You will collaborate with statisticians, data managers, and clinical teams to ensure accurate, compliant programming deliverables, contribute to ISS/ISE activities, support regulatory submissions, and work in an agile environment following CDISC standards and

Qualifications

• Proficiency in R programming.

Responsibilities

• Develop, validate, and maintain ADaM datasets, TLFs, and analytical outputs for trials.

Skills

R programming

SAS programming

ADaM dataset development

TLF programming

CDISC standards

Cross-functional teamwork

Oncology experience

Tools

GSK tools

Job description

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