Associate Director, Clinical Data Scientist - Statistics (India)
Takeda Pharmaceutical
Location
🇮🇳 India
Type
full_time
Salary
Undisclosed
Posted
2w ago
Job Description
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Job Description
Objective / Purpose: - Serve as an Associate Director-level clinical data science leader within Data & Quantitative Sciences, translating complex clinical, biomarker, and external data into actionable evidence that informs clinical development decisions. - Lead fit-for-purpose statistical, data science, and advanced analytics approaches across assigned studies, assets, or specialty areas, including exploratory analysis, predictive modeling, simulation, and integrated data review. - Partner cross-functionally with Clinical, Clinical Pharmacology, PSPV, Clinical Data Management, Translational Sciences, Regulatory, Clinical Operations, and external partners to ensure high-quality, traceable, analysis and submission-ready data and decision-ready insights. - Advance modern ways of working by applying AI/ML, automation, reusable analytics workflows, and governed data standards while maintaining scientific rigor, regulatory awareness, and patient-focused decision making. Accountabilities: - Design and/or execute quantitative analyses using clinical trial data, biomarkers, real-world data, external data, and other relevant sources to generate interpretable insights for study teams and governance forums. - Apply appropriate statistical, machine learning, simulation, and visualization methods to support patient-level prediction, endpoint interpretation, risk assessment, scenario planning, and evidence generation. - Perform end-to-end data analyses, from hypotheses formulation, experimental design, writing analysis plans, data cleaning, executing analysis, and preparing reports and documentation. - Provide or identify internal and external statistical expertise and capacity to support development activities. - Lead clinical data science strategy and delivery for one or more studies, assets, or capability areas, ensuring alignment with development objectives, timelines, quality expectations, and stakeholder needs. - Provide scientific and technical oversight of internal and external delivery partners, including review of analysis plans, specifications, code, outputs, data visualization, and interpretation of findings. - Identify, communicate, and mitigate risks related to data quality, analytic assumptions, vendor delivery, timelines, reproducibility, and regulatory acceptability of data science outputs. - Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level. - Partner with Clinical Pharmacology PSPV, Translational Sciences, Clinical Data Management, Regulatory, and platform teams to ensure that CDISC, submission, and downstream quantitative decision-making needs are built into study setup, data review, and reporting processes. - Define