无锡 [切换城市] 无锡招聘无锡生物/制药/医疗器械招聘无锡生物工程/生物制药招聘

Regional Statistician

阿斯利康药业(中国)有限公司

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:医疗/护理/卫生

职位信息

  • 发布日期:2014-05-30
  • 工作地点:泰州
  • 招聘人数:1
  • 工作经验:十年以上
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位月薪:面议
  • 职位类别:生物工程/生物制药  

职位描述

Responsibilities:

1.数据支持和分析

Statistical Support / Analysis

- 熟练运用数据分析软件,例如SAS, S-Plus, R, MINITAB, Northwest Analytics Software及其它操作软件;

Makes extensive use of statistical software packages such as SAS, S-Plus, R, MINITAB, Northwest Analytics Software, and other data manipulative software;

- 确保与产品、纯化水系统和环境监控等的趋势分析相关系统的可持续性;

Leads and provides sustainability to the trending program for product, purified water systems and environmental conditions;

- 为产品年度回顾、数据评估和生产工艺控制等提供评估数据;

Provides statistical evaluations for Annual Product Reviews and statistical evaluation and implementation of manufacturing process controls;

- 设计有效的实验并进行分析;

Designs and analyzes efficient experiments;

- 为工厂内其他用户设计和开发数据分析应用程序,供在线监控和数据分析用;

Designs and develops statistical applications for use by others within the site for on-going monitoring and analysis of site data;

- 执行专门的工艺数据评估,以支持工厂间的技术转移;

Executes ad-hoc evaluations of process data in support of technology transfers to the sites;

- 开发并应用生产物料/产品包材等的取样和趋势分析程序。

Develops and implements sampling and trending programs for materials used in the manufacture and/or packaging of products.


2.数据统计分析专业技能/咨询

Statistical Expertise / Consulting

- 为关键的药品/程序运作及项目活动提供专业的数据分析及解决问题的方法和咨询;

Serves as consultant / expert by providing statistical expertise and problem solving into key drug product/process functional and project related activities;

- 提供并推动创新性的以业务提升为核心的数据分析方法;

Proposes innovative business focused statistical approaches;

- 积极主动地识别工厂内部可以运用数据分析来提高效率、创造效益的方面;

Proactively determines where statistical practices can create efficiencies and effectiveness at the sites;

- 与区域和全球的AZ数据分析师建立合作伙伴关系;

Partner with AZ statisticians regionally;

- 协助建立质量保证相关的计算机系统(包括人员培训);

Assists in the development of computer systems designed (as well as personnel training);

- 能够成为一个技术资源顾问,在员工和管理层中传授和分享数据分析经验。

Serves as a technical resource to educate and share knowledge about statistical analysis with colleagues and team members both laterally and horizontally in the organization.


3.质量调查

Quality Investigations

- 编制数据评估方案,监督方案的执行,收集并评估数据;

Writes Statistical evaluation Protocols and oversees their execution to collect data and statistically evaluate it;

- 分析调查评估结果中的数据,进行总结,必要时需提出进一步工作建议;

Analyzes data from investigation evaluations, summarizes conclusions and makes recommendations for further work where necessary;

- 运用最高级的数据分析方法和程序以保持数据的更新状态,使符合制药行业尤其是FDA的规定及要求;

Maintains an up-to-date status with state-of-the-art statistical and analytical methods and procedures consistent with the pharmaceutical industry and in particular the FDA;

- 根据需要,代表整个工厂参加亚太区或全球质量改进小组。

As required, represents the site in regional or global quality improvement teams.


4.安全环境健康责任

SHE responsibilities

- 确保职责范围内的各项运作符合相关法律法规,AZ SHE要求和工厂内部规定。

Ensure the operations in his/her area complies with all relevant laws, regulations, AstraZeneca SHE Standards, and internal guidelines.


Requirements:

1.本科或硕士以上学历,统计学、工程学、数学或生命科学相关专业。

Bachelor Degree or master degree in Statistics, Engineering, Mathematics or one of the life sciences.

2.

- 熟练使用相关数据分析包;

Expert user of several statistical packages;

- 熟练使用数据分析软件(如SAS等)和计算机应用程序;

A working knowledge of statistical analysis software (e.g., SAS etc.), along with PC application experience;

- 将数据分析方法广泛运用于制药生产/研究领域的工作经验;

A working knowledge in applying a wide range of statistical analyses to a pharmaceutical production/research environment;

- 熟悉cGMP,药典,法规和指南;

Knowledge and familiarity with cGMPs, compendia and regulatory standards and guidelines;

- 良好的写作和沟通能力;

Excellent written and oral communication skills;

- 有以下概念的运用经验:

Experience in applying the concepts of:

  • 统计质量控制Statistical Quality Control
  • 线性建模Linear modeling
  • 实验设计Experimental Design
  • 抽样调查Survey Sampling

- 探索性数据分析。

Exploratory Data Analysis.


3.十年以上数据分析、制药(QA)或相关研究工作经验。

10 years plus of statistical experience, Pharmaceutical QA or research experience.

4.熟练运用中文和英语进行交流。必须能够对内部和外部人员或法规机构的一般诉求和投诉及时作出回复。必须能够向管理层提供及时有效的信息。

Speak English and Chinese. Must be able to respond to common inquiries or complaints from internal and external customers or regulatory agencies. Must be able to effectively present information to management.


5.电脑使用熟练。

Good Computer skill.

公司介绍

阿斯利康1993年进入中国市场。20多年来,我们不断吸引人才,通过科研创新以及卓越的执行力,真正改变患者的生活,以不断满足中国的医疗需求。中国是阿斯利康最重要的市场之一,也是我们的增长引擎。我们致力于对中国市场的长期投入。阿斯利康中国积极履行社会责任,通过与利益相关者的密切合作,以及支持身边社区的可持续发展,为中国实现构建和谐社会的目标贡献力量。

我们的愿景——开拓创新,造福病患,成为中国最值得信赖的医疗合作伙伴。

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联系方式

  • Email:recruitment.taizhou@astrazeneca.com
  • 公司地址:地址:span天河路230号万菱中心