主要编程领导者

欧洲杯微信买球Astrazeneca Pharmaceuticals LP.

标题：主要编程领导者

地点：Gaithersburg，MD

小时/周40小时

职责：作为战略性的计算机规划领导者，为临床开发过程的各个方面提供支持，包括临床开发计划，监管提交，编程和信息可交付成本，商业化和科学利用数据，用于阿斯拉替纳产品。欧洲杯微信买球通过这些合作伙伴的临床数据库的规范和交付临床数据库，引导技术咨询专业知识。监督所有可交付成果的质量，持有合作伙伴和提供者对其可交付质量负责。对监管提交的规划支持，包括规范和交付概述数据基础，输出和对监管问题的响应。确定改进方法的机会，为问题提供实际解决方案。有助于开发最佳做法，以提高质量，效率和效力。

REQUIREMENTS: Must have a Bachelor’s degree or foreign equivalent in Computer Engineering, Electrical Engineering, Computer Science, Mathematics or a related technical field plus seven (7) years of progressively responsible experience in the position offered, as a Statistical Programmer, Programmer Analyst or a related position. Must have seven (7) years of progressively responsible experience in the pharmaceutical industry with: SAS Programming for Clinical Trials; Application of Statistical concepts to evaluate safety and efficacy of a drug in Clinical Trials using SAS/EG, SAS/BASE, SAS/STAT, SAS/GRAPH and R; Technical and Regulatory requirements for Clinical Trials Programming including 21 CFR – Part 11, ICH E3, E6, E9, and eCDT; Electronic submission of Clinical Trial Data to Regulatory Agencies (Worldwide) and e-CTD (Electronic Common Technical Document) guidance; New Drug Development process, including interdependencies with cross-functional teams; Clinical (CDSIC – Clinical Data Interchange Data Consortium ) standards and Good Clinical Practices. In the alternative, Employer will accept a Master’s degree in a stated field of study plus five (5) years of experience. Any suitable combination of education, training or experience is acceptable.

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欧洲杯微信买球Astazeneca拥有多样性和机会平等。我们致力于构建一个包含所有背景的包容性和多样化的团队，尽可能广泛的视角，并利用行业领先的技能。我们相信，我们的包容越多，我们的工作就会越好。我们欢迎并考虑申请加入我们的团队从所有合格的候选人，无论其特征如何。我们遵守就业（和招聘）的非歧视以及工作授权和就业资格验证要求的所有适用的法律法规。