Data Scientist Specialist

6 days ago

mount, India beBeeStatistical Full time

Statistical Programmer OpportunityWe are seeking a skilled Statistical Programmer to join our team. As a key member of our clinical development team, you will be responsible for the development and maintenance of ADaM datasets, TLFs, and analytical outputs for clinical trials with accuracy and regulatory compliance.Develop and maintain ADaM datasets, TLFs, and analytical outputs for clinical trials with accuracy and regulatory compliance.Support Oncology studies by ensuring consistency and regulatory adherence in programming deliverables.Contribute to Integrated Summaries of Safety (ISS) and Integrated Summary of Efficacy (ISE) activities, including dataset integration, analysis, and documentation.Work closely with statisticians, data managers, and clinical teams to ensure timely delivery of high-quality programming outputs.Assist in regulatory submissions and respond to requests for quality (RTQs) by providing clear, compliant, and traceable programming outputs.Collaborate in an agile environment, participating in sprint meetings, planning, and continuous improvement discussions.Utilize internal tools and platforms, following established standards and governance, while working on cutting-edge statistical programming projects.Troubleshoot complex data/programming issues and propose process enhancements to improve efficiency.Ensure strict adherence to CDISC standards, good programming practices, and audit-ready documentation throughout your work.Minimum 4-14 years of industrial experience in statistical programmingProficiency in R programming languageStrong learning intent and ability to quickly upskill (considered for intermediate candidates)Solid experience in SAS programming, particularly in a clinical/biostatistics environmentHands-on expertise in ADaM dataset development and TLF programmingGood understanding of CDISC standards and clinical trial data flowExcellent problem-solving skills, attention to detail, and ability to work effectively in cross-functional teamsAdvanced or Expert-level R Programming skillsExperience working on Oncology therapeutic area studiesExposure to ISS/ISE, submission workflows, and regulatory interactions (e.g., RTQs)Practical understanding of agile ways of working (Scrum/Kanban)Prior experience using or supporting GSK tools and platforms

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    mount, India beBeeData Full time

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    mount, India beBeeDataIntegration Full time

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    mount, India beBeeDataAnalyst Full time

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    mount, India beBeeData Full time

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