Principal Scientist Biostatistics

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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. 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 guidance. 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. Is an evolving leader for providing input to team in terms of optimizing study or trial designs in line with study or indication level objectives and 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.

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.

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

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