Clinical Data Specialist

6 days ago

bangalore, India beBeeOncology Full time

Key ResponsibilitiesWe develop and maintain clinical trial data sets to ensure their accuracy, consistency, and compliance.We support oncology studies by ensuring the quality of our programming deliverables and regulatory compliance.We contribute to integration analysis and documentation, working closely with cross-functional teams.We assist in regulatory submissions and quality reviews, providing clear and compliant programming outputs.We participate in agile workflows, collaborating on sprint planning and continuous improvement discussions.We work with internal tools and platforms, adhering to established standards and governance.We troubleshoot data and programming issues, proposing process enhancements and improvements.We ensure adherence to industry standards and good programming practices.Required Skills & Qualifications4-14 years of industrial experience.We require proficiency in R programming and intermediate candidates with strong learning intent.Solid experience in SAS programming is essential, especially in a clinical/biostatistics environment.Hands-on expertise in ADaM dataset development and TLF programming is required.A good understanding of CDISC standards and clinical trial data flow is necessary.Strong problem-solving skills, attention to detail, and ability to work in cross-functional teams are essential.BenefitsOpportunity to work on impactful oncology research projects with global teams.Continuous learning and upskilling opportunities.Collaborative and agile work culture.Exposure to end-to-end statistical programming lifecycle and regulatory submissions.Professional AdvantagesPrior experience using or supporting GSK tools and platforms is an advantage.Experience working on oncology therapeutic area studies is beneficial.Practical understanding of agile ways of working and Scrum/Kanban methodologies is preferred.Advanced or expert-level R programming skills are advantageous.

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