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Senior, niche clinical data science role at Tier-1 pharma in Bangalore attracts moderate competition from experienced specialists.
High because expertise in clinical trials, CDISC standards, and regulatory submission is industry-specific.
High due to specific advanced degree, explicit years, regulatory submission experience, and domain-specific technical requirements.
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Lead clinical data science strategy, delivery, and team capability across assigned clinical studies and portfolios to ensure submission readiness and high-quality regulatory outputs.
Manage and develop a team of clinical data scientists, overseeing resource planning, execution, and fostering scientific rigor and collaboration within regulated clinical development.
Partner cross-functionally to translate complex clinical, biomarker, real-world, and external data into actionable evidence informing clinical development, regulatory submissions, and governance decisions.
PhD in statistics, biostatistics, data science, epidemiology, biomedical engineering, computer science, or related field with 8+ years of relevant experience; or MS with 12+ years experience.
Experience in clinical development in pharmaceutical/biotech/healthcare research with involvement in regulatory submissions and global health authority interactions.
Demonstrated people management experience including coaching, performance management, and team leadership.
Expert knowledge of clinical trial design, submission standards (CDISC, SDTM, ADaM), regulatory requirements (FDA, EMA, PMDA, NMPA, MHRA), and proficiency with R or Python.
Senior leader comfortable operating at the intersection of clinical data science, regulatory strategy, and submission preparation in global pharmaceutical contexts.
Experienced in managing cross-functional teams and external partners to deliver inspection-ready, reproducible clinical data analyses on complex portfolios.
Strategic thinker skilled in driving modern clinical data science practices including AI/ML, automation, and advanced analytics within a regulated environment.