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KEY ACCOUNTABILITIES:
1,May participate a lead statistician in dossier submission preparation
2,This individual serves as a representative of the Biostatistics platform on clinical teams and is responsible for leading the development of a product from the platform standpoint. He/she takes a leadership role in projects upto and including participation in the preparation of a dossier for submission. He/she also may represent the Biostatistics platform at external meetings with regulatory agencies and key opinion leaders.
3,Manages and follow-up the activities that are outsourced to external partners (CROs), inlcuding submissions
4,Participates and provides statistical support in the preparation of major decision-making meetings
5,Completes statistical section of the iCSR and provides a critical review
6,Completes statistical section of the iCSR and provides a critical review
JOB-HOLDER ENTRY REQUIREMENTS:
1,At least a MS degree, PhD preferred, in statistics or a related field and 4-8 years of experience in the pharmaceutical industry or equivalent qualification/experience.
2,Demonstrated experience with SAS software and awareness of current features of SAS; this includes the use of SAS Base, Statistics, and Graphics.
3,Ability to work in a multidisciplinary team. Good knowledge of statistics and its application as it applies to vaccine trials.
4,Good oral and written communcation skills. Ability to lead a project(s) while providing supervision of others. Dossier submission experience
5,Strong English language ability in both oral and writing, excellent communication and problem solving skills.
企业介绍:
赛诺菲-安万特集团公司业务遍及全球五大洲,100多个国家和地区,是欧洲第一、世界第三大制药集团,拥有10万名员工服务于全球的健康事业。 赛诺菲-安万特的人类疫苗业务-赛诺菲巴斯德是全球最大的疫苗公司之一,总部设在法国里昂。产品种类众多,进行工业化生产的产品有:流感疫苗、儿童联合疫苗、旅行者/地方病疫苗和脑膜炎疫苗等。 1996年,深圳赛诺菲巴斯德生物制品有限公司在深圳注册成立。 赛诺菲巴斯德视员工为最宝贵的资源,并积极努力帮助员工得到最大限度的发展。我们欢迎各方人才加入到我们之中。 |
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