Takeda
Website:
takeda.com
Job details:
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Job Description:
Job Description:
- 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:
- 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.
- 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.
- Define requirements for model-ready datasets and analytics-ready data flows, including variable derivations, data quality expectations, lineage, traceability, metadata, and documentation sufficient for regulated clinical development use.
- 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.
- 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.
- Drive continuous improvement in clinical data science practices through reusable code, standards, training, mentoring, automation, AI-enabled workflow improvements, and adoption of industry best practices.
- Mentor junior colleagues or delivery partners in clinical data science methods, reproducible analytic practices, technical problem solving, and effective communication of quantitative insights.
Key Requirements:
- 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 8+ years of relevant experience. Equivalent combinations should be reviewed with HR.
- Significant experience in clinical development within the pharmaceutical, biotechnology, or healthcare research environment, with demonstrated ability to influence cross-functional decisions at study, asset, or functional level.
- Experience providing technical leadership, matrix leadership, vendor oversight, and/or mentorship of junior colleagues or delivery partners.
Highest-priority Technical Skills:
- Advanced 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 uncertainty communication.
- Hands-on proficiency in R and/or Python, with working knowledge of SAS and SQL; ability to review and guide 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 and interpreting diverse data sources, including clinical trial, biomarker, real-world, external, imaging, digital health, or other high-dimensional data as appropriate to the portfolio.
- Practical understanding of AI/ML and advanced analytics in regulated clinical development, including model development, validation, documentation, bias/assumption assessment, 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.
Behavioral Competencies:
- Communicates complex quantitative findings clearly to scientific, operational, technical, and senior leadership audiences.
- Influences across functions without relying on direct authority; builds trusted partnerships with clinical, statistical, programming, data management, regulatory, technology, and vendor stakeholders.
- Balances scientific rigor, speed, quality, and pragmatic delivery; proactively escalates risks with options and recommendations.
- Demonstrates enterprise mindset, curiosity, continuous improvement, and commitment to developing others and advancing modern clinical data science capabilities.
Benefits:
It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are
Competitive Salary + Performance Annual Bonus
- Flexible work environment, including hybrid working
- Comprehensive Healthcare Insurance Plans for self, spouse, and children
- Group Term Life Insurance and Group Accident Insurance programs
- Health & Wellness programs including annual health screening, weekly health sessions for employees.
- Employee Assistance Program
- 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
- Broad Variety of learning platforms
- Diversity, Equity, and Inclusion Programs
- No Meeting Days
- Reimbursements – Home Internet & Mobile Phone
- Employee Referral Program
- Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)
About ICC in Takeda:
- Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day.
- As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.
Locations:
IND - Bengaluru
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
Locations:
IND - Bengaluru - Research and Development
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
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