16602 Biometrics and Data Sciences Senior Manager
＜Statistical activities for CSR＞
・Provide statistical input into the design of protocols including preparation of the statistical analysis section
・Ensure protocol review protocol for development of statistical analysis plan.
・Ensure preparation of statistical analysis plans including table shells.
・Ensure provision of specification for analysis/submission data and SAS datasets based on specification in accordance with company standard and CDISC ADaM/SDTM model
・Ensure development analysis programs and provide analysis outputs based on SAP and Table shell.
・Ensure working with study team members in providing data listings for data review, ESEC meeting and etc.
・Ensure provision of analysis outputs for request from other department and analysis outputs for answering to query from other countries’ authority.
＜Statistical activities for (s)NDA and after (s)NDA＞
・Ensure preparation of statistical analysis plan for ISS/ISE for CTD and provision of analysis outputs working with Global stat members.
・Ensure filing documents in statistical tasks for J-NDA.
・Ensure preparation for GCP inspection by PMDA after Japan NDA and work with study team members for inspection.
・Ensure preparation for response to PMDA query for statistical issues and analysis outputs for answering query.
・Ensure preparation for PMDA consultation.
＜Activities for CRO management＞
・Select CRO in the case of using outsourcing for statistical tasks of the study.
・Contract with CRO
・Monitor progress of statistical activities in CRO and manage deliverables from CRO appropriately.
＜Activities / as Line Manager＞
・Supervise and lead biostatisticians as line manager.
・Lead biostatisticians as group manager and manage resources, budget, and project priorities and timeline
・Propose improvement of issues in statistical tasks to department
・Collaborate with global stat group for improvement if necessary
・Computer skills: detailed knowledge and experience of using SAS system; knowledge of MS Office program suite
・Good communication skill to work in a team environment with medical personnel, clinical monitors, data managers, medical writers in project/study team including global functions and related persons in CRO.
・Knowledge of statistical method and experience of development of SAP and analysis output with SAS programming
・Good programming skill of SAS
・Knowledge of SDTM/ADaM in CDISC and experience of development of it
・Knowledge of basic medical and pharmaceutical science needed in statistical analysis
・Knowledge of clinical trial design, basic data management process
・Good English communication skills without issue in collaboration with global members.(TOEIC score: 730 is preferable)
・Experience of providing analysis outputs for ISS/ISE in CTD
・Experience of participation in Japan NDA including PMDA GCP inspection and answer to PMDA query collaborating with global stat members
・Knowledge of FDA/ICH guidelines, Japan regulation and industry standard practices regarding statistical analysis
＜as Line Manager＞
・Experience of leading biostatisticians as line manager
・Experience of managing resource and budget