Johnson & Johnson Careers

Principal Statistician

Leiden, Netherlands
Biostatistics


Job Description

Requisition ID: 1905726473W

The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for Pre/Early/Late Clinical Development, Research & Discovery, Medical Affairs, Real World Evidence, or Manufacturing Sciences programs for research, development, and/or marketed product needs in Janssen, with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents Statistics & Decision Sciences (SDS) for cross-functional and intra-departmental teams or working groups. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.
 
Position Core Competencies, Responsibilities and Accountabilities

  • Expertise: Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support.Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability. 
  • Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting.Understands and aligns with relevant regulatory guidances. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Ensures that documents, specifications, programs, andmacros are consistent and comply with project and company standards. Follows best practices for Data Integrity. 
  • Drug Development: Demonstratesthorough knowledge of pharmaceutical research and development strategies and execution. Takes a lead in providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications. Is accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.Is an evolving leader for providing input to team in terms of optimizing study or trial designs in line with study or indication levelobjectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functionalarea knowledge. 
  • Disease Area Knowledge: Demonstrates knowledge for at least one disease area/target. 
  • Innovation: Suggests and performs the evaluation of alternative or innovative approaches to statistical methods or business processes. 
  • Representation: Represents Statistics & Decision Sciences for cross-functional and intra-departmental teams or working groups relating to scientific or process initiatives. 
  • External Engagement: Participates as a member of professional organizations, e.g.by attending meetings as chair or presenter.  
  • Mentor: Supervises contractors/special assignment personnel/interns/co-ops as required.Mentors junior colleagues in techniques, processes, and responsibilities. 
  • Process: Participates in process improvement or standards development initiatives. 
  • Complexity: Works on increasingly more complex programs after mastering standard ones. Proactively identifies complexity in terms Scientific, Statistical, Health Authority, Operational, and Partnership issues
  • Collaboration: Builds cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs), consultants) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity. Works cross-functionally to identify and resolve issues.
  • Communication: Has very good written, oral, and interpersonal communication skills.  Demonstrated ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners. Bridges scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence.
     

Qualifications
  • Ph.D. in Statistics or related field with minimum 3 years relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience.
  • Proficient in SAS or R programming.
  • Good written, oral, and interpersonal communication skills.
  • Ability to work independently.
  • Demonstrated ability to work in interdisciplinary contexts outside statistics.

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
Biostatistics
Requisition ID
1905726473W