Senior Statistical Programmer

JD:\nRequired Skills\nStrong programming expertise in R Programming with the ability to upskill to a proficient level quickly.\nHands-on experience in ADaM dataset creation and TLF (Tables, Listings & Figures) programming .\nGood understanding of clinical trial data standards and regulatory requirements.\nAbility to perform data validation, quality checks, and support statistical analysis activities.\nExperience working with clinical study teams, biostatisticians, and data management teams.\nStrong analytical, problem-solving, and communication skills.\nPreferred Skills\nAdvanced to expert-level knowledge in R Programming .\nExperience in:\nISS/ISE (Integrated Summary of Safety / Integrated Summary of Efficacy)\nRegulatory Submissions\nRTQs (Regulatory/Reviewer Query support)\nFamiliarity with Agile ways of working , including sprint planning, backlog management, and collaborative delivery models.\nPrior experience working with GSK tools, standards, and processes will be an added advantage.\nExposure to end-to-end clinical trial programming and submission activities.\nKey Responsibilities\nDevelop and validate ADaM datasets as per project and regulatory standards.\nGenerate and validate TLF outputs using R programming.\nSupport statistical analysis and reporting activities for clinical studies.\nParticipate in submission activities and assist in addressing reviewer queries.\nCollaborate with cross-functional teams to ensure timely and high-quality deliverables.\nFollow SOPs, industry standards, and compliance requirements throughout project execution.\nContribute to process improvements and automation initiatives using R programming.\nPreferred Experience\nExperience in clinical/statistical programming within the pharmaceutical or CRO industry.