Associate Director, Clinical Data Scientist

IND - 2028 Takeda Innovations India Private Limited; Bengaluru; Hybrid; INR 4,500,000 - 7,500,000; Full time

Benefits offered by this job

Flexible work environment

Healthcare plans

Learning & development

No meeting days

Job summary

Takeda in Bengaluru seeks an Associate Director-level clinical data science leader to translate complex data into actionable evidence guiding clinical development decisions. Lead analyses across studies, assets, and areas, partnering with Regulatory, Translational Sciences, and Data Management to ensure high-quality, submission-ready data and insights.

You will advance modern practices with AI/ML, automated workflows, and governed data standards while upholding scientific rigor and

Qualifications

• PhD in statistics/biostatistics/data science or related field with 5+ years of relevant experience; or MS with 8+ years.
• Significant experience in clinical development within pharma/biotech or healthcare research.
• Experience providing technical leadership, vendor oversight, and mentorship.

Responsibilities

• Lead clinical data science strategy and delivery for studies/assets.
• Design/execute quantitative analyses using clinical trial, biomarker, real-world data.
• Apply statistical, ML, simulation, and visualization methods.
• Define model-ready datasets, data flows, and documentation.
• Ensure CDISC, submission readiness, and data governance.
• Provide oversight of delivery partners and reproducible analytic work.
• Drive automation and AI-enabled workflow improvements.
• Mentor junior colleagues and cross-functional teams.

Skills

R/Python

SAS

SQL

CDISC SDTM/ADaM

AI/ML in regulated development

Longitudinal analysis

Cross-functional leadership

Regulatory awareness

Education

PhD in statistics/biostatistics/data science/epidemiology/biomedical engineering/computer science/quantitative sciences

MS with 8+ years in relevant field

Tools

R

Python

SAS

SQL

CDISC standards (SDTM/ADaM)

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

• 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)

Location and Work Details

IND - Bengaluru

Worker Type Employee Worker Sub-Type Regular Time Type Full time

IND - Bengaluru - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time

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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.