Principal Scientist, Biostatistics (ST7)

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.

About the role

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. This role supports 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, supporting statistical aspects of key business and regulatory commitments, contributing to program plans, and representing Statistics & Decision Sciences (SDS) in various teams or working groups.

Responsibilities

• 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, demonstrating expertise in at least one disease area/target.
• Integrates quantitative sciences with disease or functional area requirements, balancing scientific and business needs.
• 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.
• 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.
• Builds cross-functional partnerships with internal colleagues and external partners (e.g., Contract Research Organizations (CROs), consultants) to achieve results for project-specific needs.
• Represents Statistics & Decision Sciences on various teams, working groups, and health authority interactions.
• 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 and contributes as a member of professional organizations via meetings and conferences.
• Peer reviews or edits manuscripts for professional journals.
• Exhibits strong written, oral, and interpersonal communication skills, 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, or co-ops as required.
• Mentors emerging leaders in techniques, processes, and responsibilities.
• 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.
• Ensures that documents, programs, and all other deliverables are consistent and adhere to project and company standards.

Requirements

• 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.

Skills

• Required 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.

Pay

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

Benefits

• 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.
• 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.
• Service anniversary and recognition awards.
• Eligibility to participate in several insurance plans (subject to the terms of their respective plans, including for eligible dependents in some locations).

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