Job Description

Position Summary：

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. 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, assists program plans, and represents Statistics & Decision Sciences (SDS) in various teams or working groups.

The Senior 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 full 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, showcasing an understanding of the disease/scientific/functional area and compliance with health authority standards. Acts with accountability, agility, and transparency. Exhibits knowledge of pharmaceutical research and development strategies and execution.

・Acquires and demonstrates knowledge for at least one disease area/target. 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.

・Able to address complexities related to scientific, statistical, regulatory, operational, and partnership aspects. Progresses to more complex programs upon mastering standard ones.

-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.