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Principal Clinical Data Scientist

DTX Pharma, a Novartis Company - Hyderabad, Telangana, India - In-office

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DTX Pharma, a Novartis Company, is seeking a Principal Clinical Data Scientist to lead data management and clinical data operations across multiple pharmaceutical development programs. This is a Band Level 4 role responsible for managing all data management, coding, clinical data design, and data analysis planning aspects of medium to large-sized clinical studies (Phase I–IV) within the Novartis Global Development Organization. Key responsibilities include leading functional activities across multiple projects, coordinating internal and external Data Manager teams, and making strategic data management decisions at the study and project level. You will ensure consistent application of data management processes across assigned programs, increase standardization and documentation, and develop scalable training delivery models and platforms for end-to-end deliverables. The role requires representing Data Operations in audits and inspections, centralizing team alignment in audit preparation and response. You will participate in the review of clinical research protocols, reports, and statistical analysis plans; lead quality deliverables across platforms; and develop reproducible strategies to ensure high-quality outputs. This position serves as a key collaborator and strategic partner with stakeholders, ensuring pharmaceutical drug development plans are executed efficiently with timely, high-quality deliverables while maintaining Good Clinical Practices (GCP) and data-handling procedures. Required qualifications include proven experience in clinical data management, data architecture, data governance, data integration, data profiling, data quality, and data science. Strong project management skills are essential, with the ability to manage multiple tasks and projects simultaneously. Cross-cultural experience and functional breadth in managing clinical data management activities are required. You must be able to recognize and resolve protocol issues impacting database design, data validation, and analysis/reporting, with excellent communication and interpersonal skills to build effective cross-functional relationships. Proficiency in data management tools for generating listings and providing data review outputs to study teams is necessary.

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