JD:
Required Skills
• Strong programming expertise in R Programming with the ability to upskill to a proficient level quickly.
• Hands-on experience in ADaM dataset creation and TLF (Tables, Listings & Figures) programming.
• Good understanding of clinical trial data standards and regulatory requirements.
• Ability to perform data validation, quality checks, and support statistical analysis activities.
• Experience working with clinical study teams, biostatisticians, and data management teams.
• Strong analytical, problem-solving, and communication skills.

Preferred Skills
• Advanced to expert-level knowledge in R Programming.
• Experience in:
• ISS/ISE (Integrated Summary of Safety / Integrated Summary of Efficacy)
• Regulatory Submissions
• RTQs (Regulatory/Reviewer Query support)
• Familiarity with Agile ways of working, including sprint planning, backlog management, and team-oriented delivery models.
• Prior experience working with GSK tools, standards,



and processes will be an added advantage.
• Exposure to end-to-end clinical trial programming and submission activities.

Key Responsibilities
• Develop and validate ADaM datasets as per project and regulatory standards.
• Generate and validate TLF outputs using R programming.
• Support statistical analysis and reporting activities for clinical studies.
• Participate in submission activities and assist in addressing reviewer queries.
• Collaborate with cross-functional teams to ensure timely and high-quality deliverables.
• Follow SOPs, industry standards, and compliance requirements throughout project execution.
• Contribute to process improvements and automation initiatives using R programming.

Preferred Experience
• Experience in clinical/statistical programming within the pharmaceutical or CRO industry.

📌 Senior Statistical Programmer (India)
🏢 Simelabs - Digital, AI/ML, Automation, Robotics, Gen AI.
📍 India