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

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%.

＜For Internal Applicants＞

• Based on your experience and interview evaluation, the position title and level may vary.
• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
• For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.

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