Senior Statistical Programmer

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 collaborative 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.