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 biostatistician responsible for compound level (i.e., JCoT). This position supports statistical aspects of business‐critical and/or regulatory commitments.
・ 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.
・ Develop the Protocol Element Documents (PED)/protocols with protocol writers, in terms of statistical viewpoint, and contribute to the study set‐up activities (randomization, and IXRS specification etc.) with study team members.
・ Develop statistical documents for analysis planning such as statistical analysis plan (SAP), data presentation specification(DPS) in collaboration with Clinical Informatics Lead.
・ Contribute to conduct statistical analyses (with Clinical Informatics Lead) and deliver statistical results for CSR/ regulatory documents in timely manner.
・ Provide statistical interpretation of study results, and review the contents of CSR/regulatory documents.
・ Proposal statistical documents, timeliness and quality and/or input to JCoT assigned with advice/support from CB group managers
・ 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
・ Contribute to the implementation of continuous process improvements while maintain sustainable efficiency in globally consistent processes, such as data standards and process standardization.
・ Internal; JCoT, QS‐J Matrix team, Group managers in Biostatistics dept, Statisticians including CTSL in SDS of global QS for projects assigned, Statisticians in SDS China for projects assigned
・ External; PMDA, Academia related to projects assigned, Professional Societies, CRO partners outsourced for projects assigned
Span of Control:
・ Good knowledge as drug developer, such as ICH guidelines, PMDA’s guidelines and basic preference of study design in TA of projects assigned.
・ Good skill and knowledge for statistical analysis, reporting and simulation not only got methodology but also for computing/programming with R, SAS and/or another statistical package software.
・ Good written, oral, and interpersonal communication skills.
・ Demonstrated ability to work in interdisciplinary contexts outside statistics.
Group manager, Clinical Biostatistics, Biostatistics department, Quantitative Science Division, Japan R&D
Janssen Pharmaceutical K.K. (7195)