Statistical Programmer

Role Overview

The Statistical Programmer will be responsible for creating, validating, and maintaining ADaM datasets, Tables, Listings, and Figures (TLFs), as well as other analytical outputs essential to clinical trials, particularly within oncology. This role involves collaboration with statisticians, data managers, and clinical teams to ensure outputs are accurate, compliant with regulatory standards, and delivered in a timely manner.

Key Responsibilities

• Develop and validate ADaM datasets and TLFs for clinical trial analyses.
• Support oncology clinical studies by delivering consistent, accurate, and regulatory-compliant programming deliverables.
• Contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE) activities, including data integration, analysis, and documentation.
• Coordinate closely with cross-functional teams such as statisticians, data management, and clinical operations to meet deadlines and quality standards.
• Assist with regulatory submission processes and respond to regulatory technical queries by providing clear, traceable programming outputs.
• Engage in agile methodologies by participating in sprint meetings, planning, and continuous improvement sessions.
• Utilize internal platforms and GSK-specific tools in alignment with established governance and standards.
• Identify and troubleshoot data and programming issues and suggest improvements to processes.
• Maintain compliance with CDISC data standards, programming best practices, and audit-ready documentation procedures.

Required Qualifications and Skills

• Proficient in R programming language with the ability and willingness to rapidly upskill at intermediate levels.
• Strong experience in SAS programming within clinical or biostatistics contexts.
• Hands-on experience developing ADaM datasets and programming TLFs.
• Knowledgeable in CDISC standards and the clinical trial data lifecycle.
• Excellent analytical and problem-solving abilities, detail-oriented, and capable of working effectively in cross-functional teams.

Preferred Qualifications

• Advanced or expert proficiency in R programming.
• Experience specifically with oncology therapeutic area projects.
• Familiarity with ISS/ISE reports, submission processes, and regulatory communications such as regulatory technical queries.
• Working knowledge of agile frameworks like Scrum or Kanban.
• Previous exposure to or support experience with GSK tools and platforms.