Principal Statistician

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 

The Principal Statistician will also support development and implementation of innovative approaches, participating in their hands-on implementation through direct interactions with statisticians. This involves, but is not limited to, identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up.

RESPONSIBILITIES: 

• Statistical Modeling & Methodology: Support broad implementation of innovative statistical approaches across the development portfolio. Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs. Identify opportunities for innovation; interact directly with statisticians and other QS scientists for early identification of opportunities for innovative approaches. Participate in training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other stakeholder groups) to ensure awareness and adequate knowledge about these methods. Keep up-to-date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model-based methods, etc. May engage in external collaborations within professional associations (e.g., ASA, IBS, SCT, ISoP, ISCB, PSI, EFPSI), participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals. Knowledge of biostatistics applied to clinical trials and model-based drug development. Some experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations).
• 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’s. 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: 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.