◆Job Purpose
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.

◆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.