Senior Manager, Clinical Data Scientist

Takeda Pharmaceutical Co.; Bengaluru; On-site; INR 4,500,000 - 8,000,000; Full time

Job summary

Takeda Pharmaceutical Co. in Bengaluru is seeking a Senior Manager-level Clinical Data Scientist to apply statistical, data science, and analytical methods to support clinical development programs.

You will partner with cross-functional study teams to deliver analysis-ready data, perform quantitative analyses, interpret results, and generate decision-support insights, while driving automated workflows and AI/ML-enabled approaches with regulatory rigor.

Qualifications

• PhD in statistics/biostatistics/data science or related field with 5+ years of relevant experience; or MS with 7+ years.
• Experience supporting quantitative analyses and data science activities in regulated clinical development environments.
• Ability to contribute to clinical development decisions through quantitative analysis and clear communication.

Responsibilities

• Execute clinical data science activities for assigned studies and deliver high-quality analyses.
• Perform exploratory analyses, data visualization, and quantitative assessments.
• Collaborate across Clinical Data Management, Statistical Programming, and Translational Sciences.
• Translate questions into analysis-ready datasets and reproducible workflows.
• Identify data quality risks and report them to stakeholders.
• Apply statistical, ML, simulation, and visualization methods to interpret study results.
• Review outputs for quality, traceability, and reproducibility.
• Contribute to standards, automation, and reusable analytics workflows.
• Share expertise and mentor less experienced team members.

Skills

Clinical trial design

Statistics and quantitative methods

R/Python

SAS/SQL

CDISC SDTM/ADaM

AI/ML in clinical development

Regulatory & GxP knowledge

Data platforms & automation

Visualization & interpretation

Scientific communication

Education

PhD in statistics/biostatistics/data science

MS in related field

Tools

R

Python

SAS

SQL

CDISC Define-XML

Job description

Job Description

Objective / Purpose:

• Serve as a Senior Manager-level Clinical Data Scientist within Data & Quantitative Sciences, applying statistical, data science, and analytical methods to support clinical development programs.
• Partner with cross-functional study teams to deliver analysis-ready data, perform quantitative analyses, interpret results, and generate decision-support insights.
• Deliver fit-for-purpose statistical, data science, and advanced analytics activities for assigned studies and study-level workstreams.
• Collaborate with Clinical, Clinical Pharmacology, PSPV, Clinical Data Management, Translational Sciences, Regulatory, Clinical Operations, Statistical Programming, and external partners to support high-quality, traceable, analysis-ready, and submission-ready data.
• Apply modern clinical data science practices, including automation, reusable analytics workflows, and AI/ML-enabled approaches, while maintaining scientific rigor, regulatory awareness, and patient-focused decision making.

Accountabilities:

• Execute clinical data science activities for assigned studies, ensuring timely delivery of high-quality analyses, data review, and quantitative insights that support study objectives.
• Perform exploratory analyses, data visualization, and quantitative assessments using clinical trial, biomarker, external, and real-world data sources.
• Collaborate with Clinical Data Management, Clinical Pharmacology, PSPV, Clinical Operations, and Translational Sciences to support study objectives and evidence generation.
• Translate scientific and clinical questions into analysis-ready datasets, specifications, and reproducible analytical workflows.
• Support integrated data review activities by identifying data trends, inconsistencies, and potential risks requiring further investigation.
• Apply established statistical, machine learning, simulation, and visualization methods to support interpretation of study results and development decisions.
• Contribute to the review of analysis outputs, visualizations, and technical documentation to ensure quality, traceability, and reproducibility of deliverables.
• Review and contribute to analysis outputs produced by internal teams and external partners, ensuring quality and adherence to established standards and processes.
• Identify and communicate risks related to data quality, analytical assumptions, timelines, and quantitative outputs to functional stakeholders.
• Contribute to continuous improvement efforts through automation, reusable code, standard methodologies, and adoption of approved technologies and workflows.
• Contribute to departmental standards, process improvements, and technology adoption initiatives as assigned.
• Share technical expertise and support onboarding and development of less experienced team member

Education & Competencies (Technical and Behavioral):

Education / Experience

• 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 7+ years of relevant experience.
• Experience supporting quantitative analyses and data science activities within pharmaceutical, biotechnology, healthcare research, or other regulated clinical development environments.
• Demonstrated ability to contribute to clinical development decisions through quantitative analysis, data interpretation, and effective 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 one or more additional data types such as biomarker, real-world, external, imaging, digital health, or other high-dimensional data sources.

Highest-priority Technical Skills

• Strong 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 communication of uncertainty.
• Hands-on proficiency in R and/or Python, with working knowledge of SAS and SQL; ability to develop, review, and support 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, analyzing, and interpreting 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.
• Knowledge of FDA, EMA, ICH-GCP, GxP, data privacy, inspection readiness, and traceability expectations relevant to clinical data and quantitative deliverables.
• Ability to develop clear analysis specifications, visualization approaches, documentation, and interpretation summaries suitable for scientific, operational, and study-team audiences.
• 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 leadership audiences.
• Builds effective working relationships across study teams and functional partners.
• Demonstrates strong technical credibility, sound judgment, and collaborative problem-solving skills.
• 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.
• 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