Senior Manager, Clinical Data Scientist Bengaluru, Karnataka Category: Data Sciences

Job description

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Job Description Objective / Purpose: • Serve as a Senior Manager-level Clinical Data Scientist within Data & Quantitative Sciences, applying statistical, data science, and analytical methods to support clinical development programs. • Partner with cross-functional study teams to deliver analysis-ready data, perform quantitative analyses, interpret results, and generate decision-support insights. • Deliver fit-for-purpose statistical, data science, and advanced analytics activities for assigned studies and study-level workstreams. • Collaborate with Clinical, Clinical Pharmacology, PSPV, Clinical Data Management, Translational Sciences, Regulatory, Clinical Operations, Statistical Programming, and external partners to support high-quality, traceable, analysis-ready, and submission-ready data. • Apply modern clinical data science practices, including automation, reusable analytics workflows, and AI/ML-enabled approaches, while maintaining scientific rigor, regulatory awareness, and patient-focused decision making. Accountabilities: • Execute clinical data science activities for assigned studies, ensuring timely delivery of high-quality analyses, data review, and quantitative insights that support study objectives. • Perform exploratory analyses, data visualization, and quantitative assessments using clinical trial, biomarker, external, and real-world data sources. • Collaborate with Clinical Data Management, Clinical Pharmacology, PSPV, Clinical Operations, and Translational Sciences to support study objectives and evidence generation. • Translate scientific and clinical questions into analysis-ready datasets, specifications, and reproducible analytical workflows. • Support integrated data review activities by identifying data trends, inconsistencies, and potential risks requiring further investigation. • Apply established statistical, machine learning, simulation, and visualization methods to support interpretation of study results and development decisions. • Contribute to the review of analysis outputs, visualizations, and technical documentation to ensure quality, traceability, and reproducibility of deliverables. • Review and contribute to analysis outputs produced by internal teams and external partners, ensuring quality and adherence to established standards and processes. • Identify and communicate risks related to data quality, analytical assumptions, timelines, and quantitative outputs to functional stakeholders. • Contribute to continuous improvement efforts through automation, reusable code, standard methodologies, and adoption of approved technologies and workflows. • Contribute to departmental standards, process improvements, and technology adoption initiatives as assigned. • Share technical expertise and support onboarding and development of less experienced team member Education & Competencies (Technical and Behavioral): Education / Experience • PhD in statistics, biostatistics, data science, epidemiology, biomedical engineering, computer science, quantitative sciences, or related field with 5+ years of relevant experience; or MS with 7+ years of relevant experience. • Experience supporting quantitative analyses and data science activities within pharmaceutical, biotechnology, healthcare research, or other regulated clinical development environments. • Demonstrated ability to contribute to clinical development decisions through quantitative analysis, data interpretation, and effective communication of evidence. • Experience working effectively on cross-functional study teams and collaborating across functional disciplines to achieve study objectives. • Experience working with clinical trial data and one or more additional data types such as biomarker, real-world, external, imaging, digital health, or other high-dimensional data sources. Highest-priority Technical Skills • Strong knowledge of clinical trial design, drug development, endpoints, estimands, biomarkers, data interpretation, and the role of analytics in clinical decision making. • Strong foundation in statistics and quantitative methods, including longitudinal analysis, survival methods, causal reasoning, simulation, predictive modeling, and communication of uncertainty. • Hands-on proficiency in R and/or Python, with working knowledge of SAS and SQL; ability to develop, review, and support reproducible analyses, code quality, version control, and validated workflows. • Working knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, Define-XML concepts, and submission-oriented data expectations. • Experience integrating, analyzing, and interpreting diverse data sources, including clinical trial, biomarker, real-world, external, imaging, digital health, or high-dimensional data as appropriate to assigned studies. • Practical understanding of AI/ML and advanced analytics in regulated clinical development, including model development, validation, documentation, assumptions, bias considerations, and fit-for-purpose deployment. • Knowledge of FDA, EMA, ICH-GCP, GxP, data privacy, inspection readiness, and traceability expectations relevant to clinical data and quantitative deliverables. • Ability to develop clear analysis specifications, visualization approaches, documentation, and interpretation summaries suitable for scientific, operational, and study-team audiences. • Familiarity with modern data platforms, reusable analytics workflows, automation, metadata-driven processes, and governed data standards. Behavioral Competencies • Communicates quantitative findings clearly to scientific, operational, technical, and leadership audiences. • Builds effective working relationships across study teams and functional partners. • Demonstrates strong technical credibility, sound judgment, and collaborative problem-solving skills. • Balances scientific rigor, quality, and timely delivery while proactively communicating risks and issues. • Demonstrates accountability for assigned deliverables and commitment to reproducible, traceable, high-quality work. • Embraces continuous learning and adoption of innovative analytical methods, automation, and AI-enabled approaches. Locations IND - Bengaluru - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Informiere dich über