天津招聘

Position： Associate Director, Biostatistics

Accountability：

  

一、Strategy

  

1.Develops and implements the plan to achieve objectives.

  

二、People management

  

1. Direct supervision of his/her subordinates(s).

  

2. Responsible for recruitment, development of his/her subordinates(s).

  

3. Coach, develop, and supports his/her subordinates(s).

  

4. Provide the oversights and the guidance in completing study deliverables according to agreed timeline following quality standard.

  

5. Inspire individuals while holding them accountable for project and study delivery and provide expert statistical input into development program.

  

6. Strategic thinker and problem resolver, who recognizes, anticipates, and solves problems, helps individuals to develop problem solving skills. Direct.

  

三、Performance and resource management

  

1. Manages and allocates internal and external resource management.

  

2. Measures and performances performance standards.

  

3. Oversees adherence to timeline, standards, processes for work assigned to the staffs.

  

四、Quality oversight

  

1.Oversees adherence to quality standards for work assigned to the staffs.

  

五、Technical excellence

  

1. Ensures expert statistical strategy input is provided to the organization by supported by direct reports.

  

2. Perform functional management review of major deliverables and supports individuals in providing excellence statistical input into design, analysis and report of clinical studies.

  

3. Provide oversight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts and bodies.

  

4.Encourages and supports individuals in investigating and applying advanced statistical methods in drug development programs.

  

六、Collaborations

  

1. Collaborate across locations and department inside and outside to ensure operational excellence.

  

2. Ability to influence peers in same function, and also other functions.

  

七、Process development

  

1. Contribute to improvement efforts, improvements agreed improvement actions and monitors effects after implementation.

  

八、Project responsibilities

  

1. For assigned projects, provides all statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself.

  

2. Writes or review key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figures (TLFs) specifications, study reports.

  

3. Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, SDTAM/ADAM data specifications, TLFs.

  

  

Qualifications：

  

1. MS or PhD in statistics or mathematics, minimum of 7-10 years in pharma or CRO industry with minimum of 2-4 years in functional or project management role.

  

2. Very good understanding of all phases of clinical development, and processes in data science.

  

3. Good understanding of various functions and expert groups contributing to drug development.

  

4. Solid knowledge of ASA and other statistical tools.

  

5. Good communication skills (Must).

  

6. Good written and spoken English (Must).

  

7. MS or PhD in statistics or mathematics, minimum of 7-10 years in pharma or CRO industry with minimum of 2-4 years in functional or project management role.

 

安斯泰来集团介绍：

安斯泰来制药集团是一家总部位于日本东京的研发型制药企业，在全球范围内研发、生产、销售创新型医药产品。我们的使命是不断提升企业价值，致力于通过创新可靠的医药产品为全世界人民的健康做贡献实现我们的存在意义。
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安斯泰来中国介绍：
安斯泰来制药（中国）有限公司（以下简称“安斯泰来中国”）是由原“山之内制药（中国）有限公司”于2005年8月更名，再于2007年4月1日，与“藤泽药品（中国）有限公司”合并而成。
安斯泰来中国以“通过提供创新而可靠的医药产品为世界人民的健康做贡献”为经营理念，秉持高度的伦理观和道德观，开展合乎法规的经营活动。在提升企业价值的使命下，发挥创造性，实现业务的持续发展，力图在中国成为受到客户、员工、相关企业、社会团体等利益相关者信赖的企业。
安斯泰来中国是安斯泰来制药集团在中国投资的全资子公司。工厂位于沈阳经济开发区，总部设在北京，在上海、北京、广州、成都、武汉、青岛和沈阳设有分公司，业务范围遍及全国大中城市，全国约有员工1000名。
安斯泰来中国目前在中国上市销售9个产品，涉及器官移植、泌尿、感染、皮肤、消化循环等多个专业领域，其中已经在器官移植和泌尿领域得到广大医生和患者的认可，处于市场领先地位。如欲了解更多详细信息，请登录安斯泰来中国网站**************************.