Manager, Clinical Data Scientist - Statistics

IND - 2028 Takeda Innovations India Private Limited; Bengaluru; On-site; INR 3,000,000 - 5,200,000; Full time

Job summary

Takeda Innovations India Private Limited in Bengaluru is seeking a Manager-level Clinical Data Scientist to apply statistics, data science, and analytics in clinical development programs. You will deliver analysis-ready data, quantitative analyses, and visualizations for studies, while ensuring regulatory rigor and patient focus.

You will collaborate with cross-functional teams on high-quality, traceable analytics, automation, and validated workflows, supporting study decisions and submission

Qualifications

• PhD in statistics/biostatistics/data science or MS with 3+ years of relevant experience.
• Experience contributing to quantitative analyses and data science activities in regulated clinical development.
• Ability to translate clinical questions into analysis-ready datasets and reproducible workflows.
• Experience working on cross-functional study teams in pharmaceutical/biotech settings.
• Familiarity with clinical trial data and other high-dimensional data types.

Responsibilities

• Perform exploratory analyses, data visualization, and quantitative assessments from diverse data sources.
• Apply statistical, ML, and simulation methods to support study decisions and results interpretation.
• Translate questions into analysis specifications and reproducible analytics workflows.
• Deliver timely, high-quality analyses and data reviews to study leadership.
• Identify data quality issues and communicate risks to stakeholders.
• Contribute to automation and reusable analytics within regulated environments.

Skills

R

Python

SAS

SQL

CDISC SDTM/ADaM

AI/ML in regulated development

Data visualization

Version control

Education

PhD in statistics/biostatistics/data science

MS with 3+ years of relevant experience

Tools

SAS

SQL

Job description

Job Description Objective / Purpose

Describe at the highest level the team where this job sits and how this role will contribute to the team’s delivery of critical function.

• 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

Primary duties and responsibilities; essential functions only.

• Perform exploratory analyses, data visualization, and quantitative assessments using clinical trial, biomarker, external, and real-world data sources.
• Apply established statistical, machine learning, simulation, and visualization methods to support interpretation of study results and development decisions.
• Translate scientific and clinical questions into analysis-ready datasets, analysis specifications, and reproducible analytical workflows with guidance from senior team members.
• 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.
• Support integrated data review activities by identifying data trends, inconsistencies, and potential risks requiring further investigation.
• 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)

Essential and desirable education and competency requirements to perform the primary responsibilities of the job.

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.
• 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.
• 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.
• Ability to create clear analysis specifications, visualization approaches, documentation, and interpretation summaries suitable for scientific, operational, and study‑team audiences.
• Working knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, Define‑XML concepts, and submission‑oriented data expectations.
• Awareness of FDA, EMA, ICH‑GCP, GxP, data privacy, inspection readiness, and traceability expectations relevant to clinical data and quantitative deliverables.
• 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.
• 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.
• Demonstrates technical credibility, sound judgment, and collaborative problem‑solving skills.
• 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

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.

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