Senior Clinical Data Scientist/Staff/Experimental Medicine Japan D&A
Basic Purpose of the Job
Supports the complete clinical/pharmaceutical drug lifecycle process (research, development, market access, and market supply) by providing:
- Strategic planning and execution
- Data transformation
- Descriptive analytics
- Diagnostic analytics
- Predictive analytics
- Prescriptive analytics
Work involves data from:
- Clinical trials
- Clinical registries
- Real-world databases
Responsibilities include providing:
- Analytics tools
- Data outputs
- Scientific inference and insights
May also:
- Act as an ExpMED Product Owner at the project/asset level
- Represent ExpMED regarding data science-related activities on projects and assets
Key Accountabilities
1. Data Transformation, Analysis & Reporting
Responsible for:
- Transforming, analyzing and reporting data from Phase I-IV clinical trials
- Supporting complex clinical studies and projects
- Analyzing data from registries and real-world databases
- Delivering analytics aligned with project and asset needs
Success Measures
- Quality deliverables
- Timeline adherence
- Feedback from development teams, Product Owners (POs), and capability managers
2. Innovation in Data Science
- Stay current with developments in data science
- Explore new transformation and analytical approaches
- Introduce innovative tools and processes inside and outside BI
Success Measures
- Quality of new analytical solutions
- Innovation impact
- Stakeholder feedback
3. Data Storytelling & Communication
- Present compelling, validated data science stories
- Explain data science concepts to stakeholders with limited technical backgrounds
- Communicate insights clearly across BI
Success Measures
- Quality and frequency of presentations
- Audience understanding and feedback
4. Specifications & Compliance
- Ensure data transformation and analysis specifications are:
- Complete
- Correct
- SOP-compliant
- GxP-compliant
Success Measures
- Quality and regulatory acceptance of specifications
5. Internal & External Support
- Support colleagues
- Support internal customers
- Support external providers on data science activities
Success Measures
- Stakeholder satisfaction
- Knowledge sharing within the CDS Community of Practice
6. Cross-Functional Leadership
- Participate in One Human Pharma working groups
- Lead ExpMED working groups when applicable
- Drive data science-related initiatives
Success Measures
- Quality of participation
- Leadership effectiveness
- Impact of working group outcomes
- Feedback from Global Product Owners and Product Owners
7. Product Owner Responsibilities (If Applicable)
- Support clinical drug lifecycle activities as an ExpMED Product Owner
Success Measures
- Product deliverable quality
- Leadership effectiveness
- Timeline adherence
- Stakeholder feedback [Senior CDS | PDF]
8. Cross-Functional Collaboration
- Foster team-based working within ExpMED
- Collaborate with neighboring functions across BI
- Perform cross-functional activities when required
Success Measures
- Quality and frequency of collaboration
- Stakeholder feedback
Regulatory & Organizational Requirements
Must understand and implement:
International Regulations
- Good Clinical Practice (GCP)
- Good Statistical Practice
- ICH regulations across all regions
Clinical Development Guidelines
- Clinical development methodologies
- Statistical methodologies
- Therapeutic Area-specific development requirements
Internal Requirements
- BI processes
- Standard Operating Procedures (SOPs)
- Clinical Development Plan requirements
Additional Regulations (when applicable)
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
Job Complexity
- Solves complex but defined problems
- Mainly operational with limited strategic impact
- Must consider requirements across multiple functions and departments
Interfaces
Works closely with teams across BI, including:
- GCO
- GPV
- Therapeutic Areas
- TMCP
- GRA
- Research
- Development
- Pharma Supply
Represents BI regarding:
- Statistical planning
- Data transformation
- Data analysis
- Regulatory requests related to trials, projects and assets
Job Expertise
Required expertise includes:
Data Science
- Understanding and application of key data science principles
- Advanced capability in:
- Planning analyses
- Data transformation
- Statistical analysis
- Interpretation of results
- Reporting
Technical
- Advanced experience with software programming languages relevant to business needs
Industry & Clinical Development
- Advanced understanding of the clinical drug development lifecycle
- Clinical trial development experience
Leadership
- Project leadership experience required
Experience Requirements
Master's Degree (MSc):
- Minimum 3 years experience in:
- Pharmaceutical industry
- CROs
- Regulatory authorities
- Academic institutions
Bachelor's Degree:
- Minimum 5 years of data science experience
Relevant deep expertise may partially compensate for years of experience.
Job Impact
Responsible for:
- Analysis of clinical drug lifecycle data at BI
- Communication of results to internal and external customers
- Independent decision-making related to analytical activities
- Delivering insights adapted to customer needs
Education Requirements
Bachelor of Science (BSc) or Master of Science (MSc) in:
- Statistics
- Mathematics
- Computer Science
- Data Science
- Psychology
- Finance
- Related quantitative disciplines
Required Capabilities
Statistical & Scientific Knowledge
- Strong statistical methodology knowledge
- Experimental design knowledge
- Clinical trial design knowledge
- Understanding of clinical trial terminology
- Knowledge of information processing in clinical development
Advanced Analytics
- Understanding of advanced statistical concepts used in Data Science
Technical Skills
- Proficient use of relevant programming/software languages
Communication
- Fluent English (Read / Write / Speak)
- Strong communication and presentation skills
Leadership
- Ability to lead and facilitate meetings
- Project leadership capability
Collaboration
- Strong teamwork
- Experience working globally and remotely
- Effective stakeholder management
Interpersonal Skills
- Ability to interact with:
- CROs
- External experts
- Management
- Internal stakeholders
Problem Solving
- Proactively identify issues
- Propose solutions
- Work independently on routine data science challenges
Cultural Awareness
- Awareness of local, global, internal and external cultures to ensure effective communication and collaboration [Senior CDS | PDF]
Quick Candidate Snapshot
Ideal profile:
- MSc + 3 years (or BSc + 5 years) in Data Science, Biostatistics, Clinical Analytics, or a related field
- Strong statistical analysis and programming skills
- Experience analyzing clinical trial, registry, or real-world data
- Understanding of clinical development and pharmaceutical R&D
- Experience with stakeholder communication and data storytelling
- Project leadership experience
- Fluent English
- Able to translate complex data into business and scientific insights