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