Senior Statistical Programmer Shivamogga

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. Valuable 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. Solid 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 cooperative 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. Apply on Kit Job: kitjob.in/job/4n3lvp