Associate Director, Clinical Data Scientist

Takeda Pharmaceutical Co.; Bengaluru; On-site; INR 3,000,000 - 6,000,000; Full time

Benefits offered by this job

Flexible work environment

Comprehensive Healthcare Insurance

Group Term Life Insurance

Health & Wellness programs

Employee Assistance Program

Job summary

Takeda Pharmaceutical Co. seeks an Associate Director-level clinical data science leader to translate complex clinical and biomarker data into evidence for development decisions.

You will lead data science strategy across studies, partnering with Clinical, Regulatory, and external partners to ensure quality, traceability, and submission-ready data. Responsibilities include designing quantitative analyses using trial data, biomarkers, and real-world sources; applying advanced analytics and

Qualifications

• Advanced knowledge of clinical trial design and endpoints.
• Experience with real-world data and external data integration.
• Regulatory awareness and traceability of data outputs.

Responsibilities

• Lead statistical analyses and data science approaches for studies and assets.
• Mentor junior colleagues and delivery partners in quantitative methods.
• Ensure CDISC standards are met in study setup and reporting.
• Drive AI-enabled workflow improvements with validated pipelines.
• Provide decision-ready insights to study teams and governance forums.

Skills

Statistical methods

R/Python

CDISC SDTM/ADaM

AI/ML in clinical development

Education

PhD in statistics/biostatistics/data science

MS in related field

Tools

SAS

SQL

Job description

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