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Position: R&D Manager (Principal Statistician), Statistical Modeling & Methodology, Statistics & Decision Sciences
Institution: Johnson & Johnson Services Inc.
Location: Chiyoda, Japan
Duties: Responsible for providing statistical expertise in clinical development programs, compound level development strategy, study design, data analysis and interpretation of results for clinical trials, as well as regulatory filings and approvals as a statistical modeling expert. This position supports statistical aspects of business‐critical and/or regulatory commitments, provides input to program plans with limited supervision
Requirements: Master degree in Statistical sciences or equivalent with 8‐12 years of relevant experience, or, PhD in Statistical sciences or equivalent with minimum 4 years of relevant experience; Good knowledge as drug developer, such as ICH guidelines, PMDA’s guidelines and trend of technical application/acceptability with regulatory agencies; Advanced skill and knowledge for statistical modeling and simulation not only got methodology but also for computing/programming with R, SAS and/or another statistical package software; Awareness of Bayesian methods and inference
   
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This position supports statistical aspects of business‐critical and/or regulatory commitments, provides input to program plans with limited supervision. Accountability: - Provide statistical expertise in clinical development programs, development strategy, study design, data analysis and interpretation of results for clinical trials; - Contribute to develop clinical development programs, development strategy and study design, in terms of statistical viewpoint, based on advanced TA/DA knowledge. - Support broad implementation of innovative statistical approaches across the development portfolio. - 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. - 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. - Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs. - May engage in external collaborations within professional associations, participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals - Identify opportunities for innovation; interact directly with statisticians and other “Quantitative Sciences” scientists (including global) for early identification of opportunities for innovative approaches. - Contribute people development through coaching and advices with line managers in Biostatistics dept. Decision Making: - Proposal statistical modeling approach to meet requirement and/or to solve issues for clinical development program. Influence: - Facilitate strategic & data‐oriented (quantitative) discussion by utilizing statistical thinking such as modeling & simulation approach - Provide statistical expertise to develop persuasive/logical data interpretation for regulatory approvals in timely manner. - Implement “state‐of‐the‐art” statistical strategies and advanced methodology - Lead the implementation of modeling & simulation approaches for development programs in Japan R&D through cross functional collaboration not only in Japan R&D but also global QS. Interface: - Internal; J‐CoT (Japan Compound Team), QS‐J Matrix team, Group managers in Biostatistics dept, Statisticians including Statistical Modeling & Methodology (SMM) in SDS of global QS for projects assigned - External; PMDA, Academia related to TA/DA assigned, Professional societies Qualifications Education and Experiences Requirements: - Master degree in Statistical sciences or equivalent with 8‐12 years of relevant experience, or, PhD in Statistical sciences or equivalent with minimum 4 years of relevant experience Skills & Knowledge Requirements: - Good knowledge as drug developer, such as ICH guidelines, PMDA’s guidelines and trend of technical application/acceptability with regulatory agencies - Advanced skill and knowledge for statistical modeling and simulation not only got methodology but also for computing/programming with R, SAS and/or another statistical package software. - Awareness of Bayesian methods and inference. - Demonstrated ability of planning, running, and documenting simulations (including, but not limited to clinical trial simulations). - Knowledge of biostatistics applied to clinical trials and model‐based drug development. - Demonstrated strong communication skills, including excellent leadership, innovative thinking, decision‐making skills and proven ability to foster team productivity and cohesiveness, act as a change agent, and adapt to rapidly changing organization and business environment. - Ability to work independently. - Demonstrated ability to work in interdisciplinary contexts outside statistics. Primary Location Japan-Tokyo-To-Chiyoda- Organization Janssen Pharmaceutical K.K. 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