Principal Scientist, Biostatistics (ST7)

Statistics & Decision Sciences Principal Scientist, Biostatistics (ST7) Statistics & Decision Sciences (SDS) is a function of Quantitative Sciences & Clinical Pharmacology. SDS comprises of Cardiopulmonary, Oncology, Immunology, Neuroscience, Medical Affairs, Post Approval Lifecycle Management, Discovery & Manufacturing Statistics, Statistical Modeling & Methodology & Consulting and Strategic Business & Computing Operations.

Position Summary The Principal Scientist provides input to the design and execution of studies and experiments for Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences programs at J&J Innovative Medicines (J&J IM), with minimal 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, contributes to program plans, and represents Statistics & Decision Sciences (SDS) in various teams or working groups.

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

Principal Responsibilities The content in this section applies to all statistical therapeutic areas and functional areas within Statistics & Decision Sciences. Specific additional responsibilities and accountabilities for individual statistical therapeutic areas and functional areas are contained in the Appendix. Expertise: - Exhibits advanced proficiency in data analytics, grounded in statistical principles with a proven record of effectively supporting programs.

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. - Ensures the application of high-quality statistical methodologies in assigned projects, showcasing an understanding of the disease/scientific/functional area and compliance with health authority standards.

Acts with accountability, agility, and transparency. - Demonstrates expertise in at least one disease area/target. Integrates quantitative sciences with disease or functional area requirements, balancing scientific and business needs. Quantitative Sciences & Clinical Pharmacology (QSCP) Global Development supports scenario simulations and sample size calculations informed by technical and disease/scientific/functional area specific knowledge. - Proactively identifies complexities related to scientific, statistical, regulatory, operational, and partnership aspects.

Progresses to more complex programs upon mastering standard ones. Innovation: - Identifies and implements advanced statistical techniques to address complex project or program features. Demonstrates a proven history of proposing, assessing, and executing successful alternative or innovative approaches to statistical methodologies or business processes. - Serves as a recognized leader, offering guidance to the team on optimizing study or trial designs in accordance with study or indication level objectives.

Enhances inferential insights while minimizing time, cost, and study risk. - Proven ability 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, and health authority interactions. 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 outputs 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. Participates in interactions with health authorities. Contributes as a member of professional organizations via meetings and conferences.

Peer reviews or edits manuscripts for professional journals. 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. Quantitative Sciences & Clinical Pharmacology (QSCP) Global Development - 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. Mentors emerging leaders in techniques, processes, and responsibilities. - 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, Manufacturing, Laboratory, 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. Progression This Principal Scientist job description applies to both Progression I and Progression II within the level. Individuals can move from Progression I to II as they demonstrate greater depth and/or breadth across the Progression Marker categories of Expertise, Innovation, Impact, and Key Behaviors in the Principal Responsibilities section above.

Principal Relationships This position reports to a director level people leader (PL9 or above) and is an individual contributor with no direct reports as defined by the J&J Scientific Career Architecture. In exceptional business need situations, the position may report to a PL8 or ST8 level individual. Supervises contractors, special assignment personnel, interns or co-ops as required. - Internal: Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical or Manufacturing Development teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, Global Development Delivery Units, Medical Affairs, Discovery, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance, Data Sciences, and Project Management. - External: Contracted Partners and Suppliers, Regulatory Authorities, Key Opinion Leaders, Academia, Professional Societies, Public/Private Consortia.

- 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 the English language. - Demonstrated ability to work in interdisciplinary contexts outside statistics.

Preferred Skills: Advanced Analytics, Biostatistics, Clinical Data Management, Collaboration, Compliance Management, Critical Thinking, Data Privacy Standards, Good Clinical Practice (GCP), Organizing, Presentation Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Research Documents, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Survey Design

The anticipated base pay range for this position is: €68,600.00 - €119,600.00

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.

We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.