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    Job · 20983881

    BENGALURU · FULLTIME

    Manager, Clinical Data Scientist

    Takeda

    Takeda

    Bengaluru · onsite · Posted 9d ago

    Sourced fromFoundit
    Not disclosed3–5 yrsfulltimeBengaluru

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    Section · 01

    About this role

    By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

    Job Description:

    Objective / Purpose:

    • Serve as a Manager-level Clinical Data Scientist within Data & Quantitative Sciences, applying statistical, data science, and analytical methods to support clinical development programs.
    • Contribute to cross-functional study teams by delivering analysis-ready data, quantitative analyses, visualizations, and interpretation summaries for assigned studies or workstreams.
    • Support fit-for-purpose statistical, data science, and advanced analytics activities under the direction of study and functional leadership.
    • Collaborate with cross-functional team members to support high-quality, traceable, analysis-ready, and submission-ready data.
    • Apply modern clinical data science practices, including automation, reusable analytics workflows, and approved AI/ML-enabled approaches, while maintaining scientific rigor, regulatory awareness, and patient-focused decision making.

    Accountabilities:

    • Execute clinical data science activities for assigned studies or workstreams, 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.
    • Translate scientific and clinical questions into analysis-ready datasets, analysis specifications, and reproducible analytical workflows with guidance from senior team members.
    • 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.
    • Review and contribute to outputs produced by internal teams and external partners, ensuring adherence to established standards, processes, and quality expectations.
    • Communicate risks related to data quality, analytical assumptions, timelines, and quantitative outputs to study leadership and functional stakeholders.
    • Contribute to continuous improvement efforts through automation, reusable code, standard methodologies, and adoption of approved technologies and workflows.

    Education & Competencies (Technical and Behavioral):

    Education / Experience:

    • PhD in statistics, biostatistics, data science, epidemiology, biomedical engineering, computer science, quantitative sciences, or related field; or MS with 3+ years of relevant experience. Equivalent combinations should be reviewed with HR.
    • Experience contributing to quantitative analyses and data science activities within pharmaceutical, biotechnology, healthcare research, or other regulated clinical development environments.
    • Demonstrated ability to support clinical development decisions through quantitative analysis, data interpretation, and clear 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 at least one additional data type such as biomarker, real-world, external, imaging, digital health, or other high-dimensional data sources.

    Highest-priority Technical Skills:

    • Working knowledge of clinical trial design, drug development, endpoints, estimands, biomarkers, data interpretation, and the role of analytics in clinical decision making.
    • Solid 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 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.
    • Ability to integrate, analyze, and interpret 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.
    • Awareness of FDA, EMA, ICH-GCP, GxP, data privacy, inspection readiness, and traceability expectations relevant to clinical data and quantitative deliverables.
    • Ability to create 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 study-team audiences.
    • Builds effective working relationships across study teams and functional partners.
    • Demonstrates 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

    Sourced from foundit

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    Section · 02

    Skills

    survival methodsData InterpretationAimlSimulationrstatisticsQuantitative methodsCDISC StandardsSASLongitudinal analysisPythonCausal ReasoningSQLData VisualizationAdvanced AnalyticsPredictive Modeling

    Section · Company

    About Takeda Pharmaceutical Company

    Takeda

    Takeda

    Tokyo

    JP

    About

    Zydus Takeda Healthcare Pvt. Ltd. is a Joint Venture between two pharmaceutical giants - Zydus Healthcare Ltd.; an India based leading Pharmaceutical Company with global footprints and Takeda Pharmaceuticals, the largest Pharmaceutical Company coming from Japan with worldwide presence.

    Industries

    BiopharmaBiotechnologyClinical TrialsHealth CareManufacturingMedical

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