1. 制定符合法规要求的最优统计分析方案，为法规事务相关材料提交提供战略性统 计支持，将数据分析结果纳入提交政府的报告和材料。

Conduct optimal statistical designs conforming to regulations and provide strategic statistical support to the regulatory submissions, and incorporate data analysis results

into reports and dossiers submitted to the government.

2. 精通和维护统计分析软件，包括为诗华中国研发和生产部门提供不同需求统计分 析技术的程序编制、测试、文件编制统计程序等。

Acquire proficiency in and maintain statistical software, including programming,

testing, and documenting statistical programs, etc. for multipurpose analytical

techniques for Ceva China Campus.

3. 设计并实施多种预测建模策略，进行研究以优化当前的统计分析流程。

Design and implement various predictive modeling strategies. Perform research to

optimize current statistical analysis procedures.

4. 对诗华中国所有新产品研发过程中的数据进行管理和统计分析，为新产品实验室 研究和临床研究提供生物统计方面的咨询与服务，包括但不限于研究方案设计、 撰写、编写统计分析计划、执行数据的统计分析及撰写统计报告等。

Implementation of management & data analysis of pre-project and pipeline project of

CEVA China, provide consultation and service on biostatistics for pre-project or

pipeline project, including but not limited to design and draft the research plans, write

statistical analysis plan, execute statistical analysis of data and draft statistical reports.

5. 整理试验及相关数据，制定分析计划，并进行常规数据统计分析（主要包含差异 分析、关联分析、回归分析、生存分析等），根据统计分析结果，规范化制作撰 稿所需使用的图片、表格及其它支持材料。

Manage experiment data, make statistical analysis plan, and execute routine statistical

analysis, which mainly include differential analysis, correlation analysis, regress

analysis and survival analysis and so on, according to the statistical analysis results,

make the figures, sheet and other support materials standardly.

6. 与实验室研发、临床研发和注册部门沟通，按照新兽药需要完成数据的统计和分 析工作。

Closely communicate with Lab Development, Clinical Development and RA Departments, and complete the date statistical alignment with China regulations.

7. 建立统计相关数据库并进行维护和管理，制定相关 SOP 和 SMP，根据需要参加 并进行相关培训。

Establish and manage statistic related database, prepare related SOP and SMP, attend

and conduct training as needed.

8. 根据需要为不同的部门提供统计支持。

Provide statistical support for different teams or departments as needed.

9. 按要求完成工作目标设定并自我评估，完成月度、季度、半年及年度工作总结和 汇报。

Complete objective settings and appraisals alignment with Ceva principle and

regulations, finish monthly, quarterly, semi-annually and annual reports.

10. 确保按照实验室生物安全管理制度操作，不发生生物安全事故。

Ensure the operating in accordance with lab Bio-safety management principle, no Bio

safety incidence occur.

11. 完成领导交办的其它工作。

Complete other duties under the authorization of BTDC Director.

岗位要求：

1. 生物学统计、生物信息学、医学统计、数据统计、流行病与卫生统计、医学、兽 医学或生物学相关专业研究生硕士(1-3 年相关工作经历) 或博士等相关专业（可 接受优秀毕业生）。

M.Sc. (1- 3 years of relevant experience) or Ph.D. in Biological statistics, Bioinformatics,

Medical Statistics, data statistics, epidemic and health statistics, medicine, Medicine,

Veterinary Medical, Biology or equivalent.

2. 具有医药行业统计研究经验，包括实验设计，线性或非线性模型以及它们的延伸， 混合效应模型，分类数据分析和常用的机器学习能力或者数据发掘技术。

statistical research experience in the pharmaceutical industry to include working with:

experimental design, linear/non-linear models and their extensions, mixed effects

models, categorical data analysis and commonly used machine learning/data mining

techniques

3. 能够按照中监所和农业部监管要求及相关行业标准设计方案并对试验数据进行 统计分析，满足注册提交需要。

IVDC and MoA regulations and industry standards applicable to the design, data

analysis of clinical trials and regulatory submissions.

4. 具备有效的信息收集和分析能力，解决棘手问题。

Ability to carry out simple to moderate level analysis and information gathering to

resolve problems on non-routine matters.

5. 具备扎实的数据分析、统计建模能力，熟练使用 SAS/R/SPSS 等统计软件

Fundamental level SAS programming required in the mainframe or distributed

platform environments; SAS, R, SPSS or a structured programming language

knowledge can be considered as equivalents.

6. 熟练使用 OFFICE 办公软件（EXCEL、WORD、PPT），熟练使用 GraphPad Prism 等 制图软件。

Be skilled in using office software (EXCEL, WORD, PPT), be skilled in using GraphPad

Prism and so on.

7. 适应偶尔加班或者周末工作以满足研发和注册部门材料提交的安排。

Requires occasional overtime and weekend work to satisfy R&D and RA submission

schedules

8. 具备良好的团队协作能力以及英语的听说读写能力。

Good interpersonal and communication skills in a team environment and good oral,

listening, reading and writing English skills.

上班地址：大兴区生物医药产业基地永兴路35号