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(Senior) Director, Statistics for Hematology Clinical Development

beigene · 上海市, 上海市, 中国; 朝阳区, 北京市, 中国

External listingfull-time16 days ago

About The Role

General Description: This position serves as a statistical lead and people manager of a statistics group for hematology clinical development Provides strategic statistical leadership at the Development Core Team (DCT) and compound level. Partners with clinical, regulatory and other teams on clinical development plans, clinical trial design, and statistical analysis plans, CSRs, scientific presentations/manuscripts and submission-related activities. Drives process improvement, training, SOP development Essential Functions of the job: Providing statistical expertise to efficient clinical development plan Lead and manage statistician group(s) supporting hematology clinical development, including trial design, development plans, and cross-functional project activities Serve as compound level statistician by facilitating the implementation of statistical analyses, providing statistical input to the CSR and scientific presentations/manuscripts, and performing statistical functions for submission related activities Participate in department process improvement by leading SOP development, enhancing statistical technical expertise and mentoring junior statisticians Interface with other functional colleagues from clinical, statistical programming, data management, clinical operation and promote the biostatistics goal and agenda. Support resource planning and study assignments. Supervisory Responsibilities: Manage a group of statisticians in hematology development in support of the ongoing trials and CDP development. Education Required: Ph.D. Other Qualifications: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 8 years relevant work experience, or a Master’s degree with a minimum of 11 years relevant work experience. Deep expertise in statistical analysis methodologies, experimental design, and all phases of the drug development process. Strong knowledge of ICH guidelines and regional regulatory requirements, with particular emphasis on APAC Health Authorities including China's CDE and Japan's PMDA. Proven track record in regulatory activities, including submissions and health authority interactions. Demonstrated skill in the planning, analysis and reporting of clinical trials. Solid working knowledge of statistical and data processing software e.g. SAS and/or R. Analytical thinking skills with the ability to build strategic working relationships and make sound decisions. Strong project and people management skills, including ability to manage scope and effectively delegate Strong presentation, oral and written communication skills. Strategic agility including problem-solving and critical thinking, and ability to drive drug development strategies beyond statistical aspects. Proactive, motivated, and detail-oriented with a consistent focus on execution. Strong interest in statistical research and application of novel methods to clinical trial development. Ability to work effectively in a cross-functional team environment. Travel: 10% 百济神州全球胜任力 当我们通过以下十二项全球胜任力,展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时,我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明: 百济神州致力于尊重和保护您的个人信息权利,并承诺依据合法、正当、必要和诚信的原则处理您的个人信息(包括个人敏感信息 )。 由于百济神州在全球范围内开展业务,我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家(例如:美国)的服务器和数据库中,详情参见百济神州《求职者隐私政策》(百济神州官网 - 隐私政策 - 求职者隐私政策)。 如您主动向我们提供您的简历信息或其他个人信息,则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的,请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.

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