Principal Statistician

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. 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 direction. 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. Role responsibilities Discovery & Translational * Serving as initial consultation contact for new projects. Maintains and grows customer base and builds loyal relationships with customers. * Assuming independence, professional responsibility for all phases of a project request from beginning through completion, with minimal direction as needed. * Managing multiple projects. * Leading Statistical Input for at least one functional area, research field, or compound. * Providing input to product development and performs statistical functions for submission related activities where appropriate. Statistical Modeling & Methodology * Support broad implementation of creative statistical approaches across the development portfolio. * Support development and implementation of innovative ways, 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. * Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs. * Find opportunities for innovation; interact directly with statisticians and other QS scientists for early identification of opportunities for innovative ways. * Participate in training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other partner 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. * You have knowledge of biostatistics applied to clinical trials and model-based drug development. * You have some experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations). * You are aware of Bayesian methods and inference. Qualifications Do You have the following Education and Experience? * Ph.D. / MSc in Statistics or related subject. * Proficient in SAS or R programming. * Good written, oral, and interpersonal communication skills. * Ability to work independently. * Able to work in interdisciplinary contexts outside statistics. 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 Primary Location United Kingdom-England-High Wycombe- Organization Janssen Cilag Ltd. (7360) Job Function R&D Requisition ID 2005818252W