Manager, Clinical Data Scientist - Statistics

Takeda

Bengaluru

On-site

INR 3,000,000 - 4,600,000

Full time

8 days ago

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Job summary

Takeda in Bengaluru is seeking a Manager-level Clinical Data Scientist to apply statistical and data science methods across clinical development programs. You will deliver analysis-ready data, quantitative analyses, visualizations, and interpretation summaries for studies and workstreams, under leadership direction.

You will support automated analytics workflows, data quality, and regulatory-compliant data outputs, contributing to cross-functional teams and high-quality decision making.

Qualifications

  • PhD in statistics, biostatistics, data science, epidemiology, or related field; or MS with 3+ years of relevant experience.
  • 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 with cross-functional study teams and collaborating across disciplines to achieve objectives.
  • Experience working with clinical trial data and at least one additional data type such as biomarker, real-world, external, imaging, digital health, or high-dimensional data.

Responsibilities

  • 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.
  • Support integrated data review activities by identifying data trends, inconsistencies, and potential risks requiring further investigation.
  • Review outputs from internal teams and external partners to ensure adherence to standards and quality.
  • Communicate risks related to data quality, analytical assumptions, timelines, and outputs to study leadership and stakeholders.
  • Contribute to continuous improvement through automation, reusable code, and approved technologies.

Skills

R
Python
SQL
Statistics

Education

PhD in statistics
MS with 3+ years experience

Tools

SAS
CDISC SDTM/ADaM
Define-XML

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

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