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About the Role

The Senior Scientist supports the design and execution of studies and experiments for Clinical Development and Medical Affairs programs at J&J Innovative Medicines (J&J IM), with evolving supervision. This role supports statistical analysis, interpretation, and reporting or communication of data evidence towards programs for research, development, and/or marketed product needs. The position collaborates with Quantitative Sciences & Clinical Pharmacology (QSCP) functions and other drug development scientists, supporting statistical aspects of key business and regulatory commitments, assisting program plans, and representing Statistics & Decision Sciences (SDS) in various teams or working groups.

Responsibilities

Supports the design and execution of studies and experiments for Clinical Development and Medical Affairs programs.
Supports statistical analysis, interpretation, and reporting or communication of data evidence.
Collaborates with Quantitative Sciences & Clinical Pharmacology (QSCP) functions and other drug development scientists.
Supports statistical aspects of key business and regulatory commitments.
Assists program plans.
Represents Statistics & Decision Sciences (SDS) in various teams or working groups.
Exhibits effective proficiency in data analytics, grounded in statistical principles.
Demonstrates competence in utilizing pertinent computational tools for research objectives.
Applies high quality statistical methodology in assigned projects.
Provides input in optimizing study designs to meet objectives.
Supports scenario simulations and sample size calculations.
Implements advanced statistical techniques to address complex project or program features.
Assesses and executes alternative or innovative approaches to statistical methodologies or business processes.
Provides input to help optimize study or trial designs.
Assists in problem-solving and troubleshooting at a program level.
Collaborates cross-functionally to identify and resolve issues.
Engages in process improvement and standards development initiatives.
Builds cross-functional partnerships with internal colleagues and external partners.
Collaborates effectively with SDS colleagues and external partners to meet program needs.
Represents Statistics & Decision Sciences on various teams and working groups.
Works within SDS and QSCP for unified and integrated quantitative input in drug development.
Delivers high-quality and timely deliverables.
Holds responsibility and accountability for individual project execution.
Manages meetings with relevant project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications.
Identifies vital external scientific and statistical trends, driving the advancement of statistical methodologies through scholarly publications.
Engages actively in presentations at key forums and publishes work addressing business-related needs.
Contributes as a member of professional organizations.
Keeps up-to-date with the changing landscapes in drug development and statistical methodology.
Shows adaptability to optimize contributions to the J&J IM pipeline.
Communicates statistical findings to program stakeholders and broader non-technical audiences utilizing interactive graphical tools.
Supervises contractors/special assignment personnel/interns/co-ops as required.
Takes responsibility and accountability for the quality and timeliness of project deliverables.
Follows best practices for Good Clinical, or other pertinent GxP activities and requirements, including Data Integrity.
Complies with organization and company standard operating procedures in a timely fashion.
Ensures that documents, programs, and all other deliverables are consistent and adhere to project and company standards.
Supports Post Marketing Surveillance (PMS) business needs in Japan.

Requirements

Ph.D. in Statistics or related field with relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience.
Proficient in SAS and R programming, and other relevant computing tools (e.g., East Horizon, RPACT, FACTS, Python).
Excellent interpersonal, verbal, and written communication skills in both of Japanese and English languages.
Demonstrated ability to work in interdisciplinary contexts outside statistics.
Follows best practices for Good Clinical, or other pertinent GxP activities and requirements, including Data Integrity.
Complies with organization and company standard operating procedures in a timely fashion, such as required training and project time accounting.
Demonstrates understanding and alignment with pertinent regulatory guidance.

Skills

Data Analytics
Statistical Principles
R
SAS
Computational Tools
Innovative Data-Adaptive Methods
Artificial Intelligence
Pharmaceutical Research and Development
Study Design Optimization
Advanced Statistical Techniques
Process Improvement
Standards Development
Cross-functional Collaboration
Communication Skills
Problem-Solving
Good Clinical Practice (GCP)
Data Integrity
Standard Operating Procedure (SOP)
Statistical Analysis Systems (SAS) Programming
Statistics
Systems Development
Technologically Savvy
Advanced Analytics
Biostatistics
Clinical Trials
Collaboration
Consulting
Critical Thinking
Data Privacy Standards
Data Quality
Data Savvy
Digital Fluency
Quality Assurance (QA)
Report Writing

Location

Chiyoda, Tokyo, Japan

Work Type

Full-time

Experience Level

Senior Scientist

Education Level

Ph.D. in Statistics or related field
Master’s in Statistics or related field

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.