[Innovative Medicine] R&D, Scientist Biostatistics, Statistics & Decision Sciences Japan, Global Development Full-time

Job Opportunity At Johnson & Johnson

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.

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.

Job Function

Data Analytics & Computational Sciences

Job Sub Function

Biostatistics

Job Category

Scientific/Technology

All Job Posting Locations

Chiyoda, Tokyo, Japan

Job Description

Position Summary

The 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. Activities associated with the role require guidance from managers and project statisticians in Statistics & Decision Sciences (SDS). Support is provided to statistical analysis, interpretation, and reporting or communication of data evidence towards programs for research, development, and/or marketed product needs in J&J IM.

The position collaborates with Quantitative Sciences & Clinical Pharmacology (QSCP) functions and other drug development scientists. This role supports statistical aspects of key business and regulatory commitments and assists program plans.

The Scientist practices J&J leadership principles and values aligned with the company's Credo and purpose.

Principal Responsibilities

Expertise:

• Exhibits effective proficiency in data analytics, grounded in statistical principles that lead to successful study support. Demonstrates competence in utilizing pertinent computational tools for research objectives related to studies, experiments, or trials, including proficiency in R and SAS, along with familiarity with other relevant computational tools including innovative data-adaptive methods and artificial intelligence.
• Applies high quality statistical methodology in assigned projects in compliance with health authority standards. Acts with accountability, agility, and transparency. Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support. Understands and aligns with relevant regulatory guidance.
• Acquires and demonstrates knowledge of drug development processes. Provides input in optimizing study designs to meet objectives, and supports scenario simulations and sample size calculations informed by technical and disease/scientific/functional area specific knowledge.
• Progresses to more complex programs upon mastering standard ones.

Innovation:

• Embraces opportunities for evaluating, recommending, and implementing successful alternative or innovative approaches to statistical methods or business processes.
• Provides input to team to help optimize study or trial designs in line with study or indication level objectives to enhance inferential insights while minimizing time, cost, and study risk.
• Assists in problem-solving and troubleshooting at a program level, including regulatory and decision-making support. Collaborates cross-functionally to identify and resolve issues.
• Engages in process improvement and standards development initiatives.

Impact:

• Exhibits interest in building internal cross-functional partnerships and relationships.
• Collaborates effectively with SDS colleagues and with external partners to achieve results for trial specific needs, with support from SDS management. Works within SDS and QSCP for unified and integrated quantitative input in drug development.
• Contributes to high-quality and timely deliverables as evaluated by stakeholders such as the project team, clinical trial team, and the Statistics Area Head. Holds responsibility and accountability for individual project execution, managing meetings with relevant project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
• Participates as a member of professional organizations, such as attending meetings and conferences.

Key Behaviors:

• Displays a proactive approach and cultivates a growth mindset for personal development. Keeps up-to-date with the changing landscapes in drug development and statistical methodology, and shows adaptability to optimize contributions to the J&J IM pipeline. Continuously grows global and big picture perspectives.
• Exhibits strong written, oral, and interpersonal communication skills, and demonstrates proficiency in collaborating with non-statisticians by translating intricate statistical concepts for drug research and development partners. Effectively communicates statistical findings to program stakeholders and broader non-technical audiences utilizing interactive graphical tools.
• Takes responsibility and accountability for the quality and timeliness of project deliverables as assessed by stakeholders from respective projects or programs. 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. Ensures that documents, programs, and all other deliverables are consistent and adhere to project and company standards

Area Specific Responsibilities and Accountabilities

The content in this section supplements the Principal Responsibilities section above. For an individual, the applicable content corresponds to their assigned area within Statistics & Decision Sciences.

Japan Post Marketing Surveillance

Post Marketing Surveillance (PMS) business needs in Japan are supported at this level, as the Pharmaceutical and Medical Devices Agency (PDMA) Japan health authority may require a marketed product in Japan to conduct a post-marketing surveillance study.

Education and Experience

• Master's Degree in Statistics or related field.
• Proficient in SAS and R programming, and other relevant computing tools (e.g., EAST, SOLARA, FACTS, Python).
• Good interpersonal, verbal, and written communication skills in both of Japanese and English languages.
• Demonstrated ability to work in interdisciplinary contexts outside statistics.

Other

• Travel (domestic or international) anticipated to be <10%.

Required Skills:

Preferred Skills:

Advanced Analytics, Analytical Reasoning, Biological Sciences, Biostatistics, Data Modeling, Data Privacy Standards, Data Savvy, Detail-Oriented, Execution Focus, Good Clinical Practice (GCP), Project Support, Report Writing, Research Ethics, Researching, Statistical Analysis Systems (SAS) Programming, Statistics, Technologically Savvy