Senior Clinical Data Scientist | Staff |医薬開発本部エクスペリメンタルメディシンジャパン Full-time

ExpMED Product Owner

Supports the complete clinical/pharmaceutical drug life cycle process (research, development, market access, market supply) by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to projects such as clinical trial data, clinical registries and real-world databases. In particular, this includes the provision of analytics tools, outputs and inference as necessary for the specific use case. May act as an ExpMED Product Owner up to substance/asset level and represent ExpMED regarding data science-related aspects at project, asset, or substance level.

Key Responsibilities

• Transform, analyze and report studies/projects including Phase I-IV clinical trials, ranging from standard studies to complex international projects.
• Design, lead and oversee the transformation, analysis and reporting of clinical trial data, registries and real-world databases for specific use cases, projects and assets.
• Keep abreast of developments in data science and identify, develop and implement innovative transformation, analysis and data science approaches.
• Turn derived insights into new data science approaches relevant for discovery, clinical development, registration, manufacturing or marketing of medicines.
• Present compelling and validated stories regarding data science aspects to colleagues and stakeholders within and outside the organization.
• Ensure data transformation and analysis specifications meet requirements for completeness, correctness, regulatory compliance, departmental guidelines and SOPs.
• Support, guide and/or lead colleagues, customers and external providers on data science-related activities.
• Participate in and/or lead cross-functional working groups across ExpMED, BI and One Human Pharma. Participate in external working groups where applicable.
• Support the clinical drug life cycle process as an ExpMED Product Owner at project, asset or substance level where applicable.
• Foster innovative digital approaches to produce sophisticated optimization solutions, innovative processes and predictive models.
• Ensure cross-functional and team-based working across ExpMED and neighboring functions.
• Fulfil tasks of other functions as needed and contribute to cross-functional thinking and collaboration.

Regulatory and Organizational Requirements

• Know, understand and implement international regulations and guidelines for good clinical and statistical practice from all ICH regions.
• Apply international clinical development guidelines, including statistical methodology for therapeutic area-related disease areas.
• Understand and apply BI processes and SOPs governing clinical development.
• Understand and apply other relevant regulations such as GLP and GMP where necessary.

Qualifications and Experience

• Bachelor's, Master's or PhD degree in Statistics, Mathematics, Computer Science or a related field (e.g., Psychology, Data Science, Finance).
• Understanding and application of key principles of data science.
• Knowledge and experience in planning, transforming, analyzing, interpreting and reporting data from clinical trials and other data sources related to the clinical drug life cycle process.
• Experience with software languages relevant to business needs.
• Experience and understanding of the clinical drug development process.
• Project leadership experience, including advanced project leadership experience for more senior candidates.
• Relevant experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions.

Typical Experience Range

• PhD: 0-3+ years relevant experience
• MSc: 3-6+ years relevant experience
• Bachelor's degree: 5-7+ years relevant experience

Required Capabilities

• Knowledge of statistical methodology and clinical trial design.
• Understanding of advanced statistical concepts related to Data Science.
• Proficiency in relevant software languages and analytical tools.
• Fluent English communication skills (written and spoken).
• Ability to lead and facilitate meetings.
• Ability to develop and deliver training related to data science topics.
• Strong teamwork skills in global and remote environments.
• Strong interpersonal and stakeholder management skills.
• Ability to proactively identify issues, develop solutions and interact effectively with internal and external stakeholders.
• Mindful of local, global, internal and external cultures to ensure effective communication.

Key Interfaces

Interact with colleagues and stakeholders across GCO, GPV, Therapeutic Areas, TMCP, GRA, Research, Development and Pharma Supply. Represent the organization in regulatory discussions related to planning, analyses and data transformation for trials, projects, assets and substances as appropriate.

Job Complexity

Solve complex defined problems within the clinical drug life cycle process, ranging from operational to strategic impact, while considering the needs and requirements of other functions and departments.