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

Innovation:

• Implements advanced statistical techniques to address complex project or program features. Embraces opportunities of assessing and executing successful alternative or innovative approaches to statistical methodologies or business processes.
• Proactively 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.
• Strongly 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:

• Builds cross-functional partnerships with internal colleagues and external partners (e.g., Contract Research Organizations (CROs), consultants) to achieve results for project-specific needs, focusing on enhancing communication, efficiency, and productivity.
• Collaborates effectively with SDS colleagues and external partners to meet program needs. Represents Statistics & Decision Sciences on various teams, working groups. Works within SDS and QSCP for unified and integrated quantitative input in drug development.
• Represents Statistics & Decision Sciences in cross-functional and intra-departmental teams or working groups pertaining to scientific or process initiatives. Delivers 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.
• 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.

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.
• Supervises contractors/special assignment personnel/interns/co-ops as required.
• 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

• 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.

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, Biostatistics, Clinical Trials, Collaboration, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy