- Spring House, PA
Janssen Research & Development, L.L.C., a Johnson & Johnson company is recruiting a Principal Statistician to be based out of Spring House, PA (remote options are available).
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC. is part of the Janssen Pharmaceutical Companies.
The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for Early/Late Clinical Development 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.
Other responsibilities include:
· 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.
· 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.
· 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.
- Ph.D. in Statistics or related field with minimum 3 or more years of relevant experience, or Master's in Statistics or related field with 6 or more years of relevant experience required.
- Full proficiency in SAS or R programming required.
- Strong written, oral, and interpersonal communication skills required.
- Ability to work independently and in a team environment required.
- Demonstrated ability to work in interdisciplinary contexts outside statistics preferred.
- Demonstrated knowledge for at least one disease area/target preferred.
- Knowledge of biostatistics applied to clinical trials and model-based drug development preferred.
- Experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations) preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)
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