Senior Clinical Data Scientist/Staff/Experimental Medicine Japan D&A Full-time

Job Title

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

Responsible for:

• 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

Responsible for:

• 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

Responsible for:

• 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

Responsible for:

• 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

Responsible for:

• 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)

Responsible for:

• Support clinical drug lifecycle activities as an ExpMED Product Owner

Success Measures

• Product deliverable quality
• Leadership effectiveness
• Timeline adherence
• Stakeholder feedback

8. Cross-Functional Collaboration

Responsible for:

• 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: