Director, Clinical Data Scientist

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

• Set clinical data science direction and delivery priorities for assigned studies, assets, portfolio areas, or capability domains, aligning work with development objectives, functional strategy, global regulatory strategy, submission timelines, quality expectations, and stakeholder needs.
• Provide people leadership for direct reports, including goal setting, performance management input, coaching, career development, workload prioritization, engagement, and support for talent growth and retention.
• Build team capability by mentoring and developing clinical data scientists, creating opportunities for technical growth, strengthening reproducible analytics practices, and promoting clear communication of quantitative insights in study, governance, and regulatory settings.
• Oversee resource planning and delivery execution across assigned work, balancing portfolio priorities, capacity, external partner contributions, submission milestones, and risk mitigation to support high-quality and timely outputs.
• Lead the design and interpretation of quantitative analyses using clinical trial data, biomarkers, real-world data, external data, and other relevant sources to generate evidence for study teams, asset teams, governance forums, health authority interactions, and regulatory submission packages.
• Guide the use of statistical, machine learning, simulation, and visualization methods to support patient-level prediction, endpoint interpretation, risk assessment, scenario planning, integrated data review, evidence generation, and submission-oriented interpretation.
• Define expectations for model-ready datasets and analytics-ready data flows, including variable derivations, data quality expectations, lineage, traceability, metadata, documentation, and fit-for-purpose use in regulated clinical development, inspections, and submissions.
• Partner with Clinical Pharmacology, pharmacovigilance, Translational Sciences, Clinical Data Management, Regulatory, Statistical Programming, and platform teams to ensure data standards, submission needs, and downstream quantitative decision-making needs are reflected in study setup, data review, analysis planning, reporting, and health authority response processes.
• Provide scientific, technical, operational, and submission-readiness oversight of internal teams and external delivery partners, including review of analysis plans, specifications, code, outputs, data visualizations, narratives, documentation, and interpretation of findings.
• Identify, communicate, and mitigate risks related to data quality, analytic assumptions, vendor delivery, resource capacity, timelines, reproducibility, inspection readiness, and regulatory acceptability of data science outputs across multiple health authorities.
• Support preparation for regulatory interactions and submissions by ensuring analytical outputs are well documented, traceable, reproducible, appropriately governed, and aligned with expectations from the Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency, National Medical Products Administration, Medicines and Healthcare products Regulatory Agency, and other relevant health authorities, as applicable.
• Drive continuous improvement in clinical data science practices through reusable code, standards, training, automation, artificial intelligence-enabled workflow improvements, governed data standards, and adoption of industry best practices for submission-ready delivery.
• Represent Clinical Data Science in cross-functional and regulatory-facing forums, helping connect quantitative insights to clinical development questions, submission strategy, health authority expectations, decisions, and patient impact.

People Leadership & Behavioral Competencies

You will serve as a Director-level clinical data science leader and people manager within Data and Quantitative Sciences. In this role, you will help shape clinical data science strategy, support high-quality delivery, strengthen submission readiness, and build team capability across assigned studies, assets, or specialty areas.

You will lead and develop a team of clinical data scientists and matrixed contributors, set clear priorities, and foster a culture of scientific rigor, accountability, inclusion, collaboration, inspection readiness, and continuous improvement. You will turn complex clinical, biomarker, real-world, external, and high-dimensional data into evidence that supports clinical development strategy, health authority interactions, regulatory submissions, governance decisions, and patient-focused decision making.

You will shape statistical, data science, and advanced analytics approaches across a portfolio, including exploratory analysis, predictive modeling, simulation, integrated data review, automation, and artificial intelligence and machine learning methods that are suitable for regulated clinical development and submission use.

You will partner with colleagues across Clinical, Clinical Pharmacology, pharmacovigilance, Clinical Data Management, Translational Sciences, Regulatory, Clinical Operations, Statistical Programming, technology and platform teams, and external partners to ensure high-quality, traceable, analysis-ready, health-authority-ready data and decision-ready insights across multiple regulatory jurisdictions.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as «hybrid» following Takeda's Hybrid and Remote Work policy.

Locations

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time