**Basic purpose of the job** 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 actual 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. **Accountabilities** 【Principal Clinical Data Scientist/Non Line Manager】 + Leads and oversees design, analysis, and reporting of complex clinical trials and international projects. + Creates and applies new data science approaches across the drug lifecycle. + Explains complex data science topics to internal and external experts. + Ensures data transformation and analysis specifications are complete, correct, and compliant with department guidelines, SOPs, and applicable GxP requirements. + Guides and leads team members and external vendors on data science-related tasks. + Leads cross-functional and external working groups on data science-related tasks. + Acts as Product Owner at the substance level to support the clinical drug life cycle process. + Drives digital innovation and advanced analytics initiatives. 【Senior Clinical Data Scientist/Staff】 + Performs analysis and reporting for clinical trials and supports complex studies. + Applies new analytical tools and processes. + Explains data science concepts to colleagues with basic knowledge. + Ensures data transformation and analysis specifications are complete, correct, and compliant with department guidelines, SOPs, and applicable GxP requirements. + Supports team members and external vendors on data science-related tasks. + Participates in One Human Pharma cross-functional working groups and leads BDS internal working groups on data science-related tasks. + Acts as Product Owner at the project level to support the clinical drug life cycle process. **Requirements** 【Common】 + Understanding and applying key principles of data science. + Ability to proactively identify issues and solutions and to interact with internal and external bodies on routine data science issues. + Ability to lead and facilitate meetings. + Evidence of strong teamwork, including in global and remote contexts. + Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g. CROs, experts, management). + Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively. + Language skills: English: fluent (Read/Write/Speak). + Master of Science (MSc) in Statistics, Mathematics, Computer Science or related field, and 3 years within the pharmaceutical industry, CROs, regulatory authorities or academic institutions 【Principal Clinical Data Scientist/Non Line Manager】 + Advanced experiences serving as the primary statistician for multiple PMDA consultations and new drug applications. + Broad knowledge and advanced experience in understanding clinical drug life cycle process (e.g. clinical trial development process). + Thorough knowledge of statistical methodology and in-depth understanding of advanced statistical concepts. + Broad knowledge and advanced experience in software languages relevant for business needs (SAS, R), including advanced working knowledge across a wide range of aspects. + Advanced project lead experience. + Ability to develop and deliver training related to data science topics. 【Senior Clinical Data Scientist/Staff】 + Experiences serving as the primary statistician for PMDA consultations and new drug applications. + Advanced experience in understanding clinical drug life cycle process (e.g. clinical trial development process). + Sound knowledge of statistical methodology and understanding of advanced statistical concepts. + Advanced experience in software languages relevant to business needs (SAS, R), with proficiency in practical use. + Project lead experience. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.