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Astek - Statistical Programmer

Astek
5 - 10 Years
Multiple Locations

Posted on: 19/08/2026

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.

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