Principal Scientist Biostatistics

Overview

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.

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.
• 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 a 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, and macros are consistent and comply with project and company standards.
• Follows best practices for Data Integrity.

Drug Development

• Demonstrates thorough 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.
• Provides input to team to optimize study or trial designs, supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.

Disease Area Knowledge

• Demonstrates knowledge for at least one disease area/target.

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.

Programming

• Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.

Innovation

• Suggets 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.

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