Biostatistician/Senior Biostatistician / 外資製薬メーカー
＜KEY TASKS ＆ RESPONSIBILITIES＞
・As a trial biostatistician for statistically routine clinical trials， with limited direction provide statistical input for concept sheet/protocol/CRF development (e.g.， trial design; sample size estimation for the most efficient and practical design; patient randomization; accurate， logical， clear， concise and thorough statistics section; effective CRF specifications to collect data specified in the protocol)， write medical and statistical supervision plans， write statistical analysis plans， provide analysis dataset specifications， and perform statistical analyses.
・As a trial biostatistician for statistically complex clinical trials， with direction provide statistical input for concept sheet/protocol/CRF development， write medical and statistical supervision plans， write statistical analysis plans， provide analysis dataset specifications， and perform statistical analyses.
・For integrated safety and efficacy summaries for regulatory submissions， with direction write statistical analysis plans and perform statistical analyses.
・For statistically routine clinical trials， with limited direction write comprehensive statistical methods sections for the clinical trial reports; review and co-author these reports ensuring the accuracy of the statistical interpretation.
・For statistically complex clinical trials， with direction write comprehensive statistical methods sections for the clinical trial reports; review and co-author these reports ensuring the accuracy of the statistical interpretation.
・May validate statistical output as required.
・Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation.
・Participate effectively on clinical trial teams.
・With direction， plan， communicate， and implement the surveillance of the statistical activities performed by a Contract Research Organization.
・Exhibit routine and complex problem solving skills.
・Keep abreast of statistical developments.
・Communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear， concise， focused and articulate manner.
・Understand and follow all Global Biostatistics WIs/SOP as well as any other relevant WIs/SOPs
|求める経験||・Preferably at least 3 years experience in the Pharmaceutical/Biotechnology industry in clinical development
・Working SAS knowledge
・Knowledge of relevant regulatory guidelines applicable to clinical development
・Familiarization with or ability to develop an understanding of relevant therapeutic areas
|年収||900万円 - 1200万円|
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＜Summary/Scope＞ The Study Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time， within budget， and of high quality in compliance with ICH/GCP， JGCP， Regulatory Authorities’regulations/guidelines， and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross-functional Japan study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO). Study manager has full responsibilities for studies led by the Japan Study Team. Responsibilities in the global study is complied with Affiliate Involvement Model (AIM)， Job aid and direction given by Global Clinical Trial Manager (CTM). Responsibilities involve a combination of execution and oversight-dependent on the sourcing model - to ensure deliverables and may include， but are not limited to， the following: -Financial Planning and Management ・Strong understanding of the cost drivers， attuned to principles of cost disciplined science and are able to proactively manage the study budget ・Takes ownership and accountability for the development/management/reconciliation of overall study budget(s) ・Development/management of vendor scope of work (SOW) per contract， quality， and budget ・Review/approval of vendor invoices and management of accruals and SOW changes ・Review/approval of site invoices and management of site budget -Project Management ・Drive study execution ・Oversight of clinical monitoring quality and adherence to established processes and plans ・Development， management， maintenance of study deliverables [i.e. timelines， study plans， etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions ・Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs. ・Maintenance/updating of data as appropriate in project management tools including CTMS ・Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans， updated forecasting， and of potential issues/mitigation -Study Planning and Conduct ・Facilitation of site feasibility/selection processes with use of robust data ・Operational and strategic input into study documents such ……（以下詳細は面談時にご案内します）
＜担当する仕事内容の詳細＞ ・承認申請書類、届出書類等の薬事監査 ・GVP、GQP自己点検 ・製造販売中止製品の承認整理、後発医薬品の薬価基準収載手続き及び削除 ・薬事規制の対象となる添付文書、製品のパッケージ、広告等の監査 ・薬事規制に係る情報等の収集・分析及び関係部署への情報提供 ・薬事に係る相談と助言等