• 无工作经验
  • 硕士
  • 招1人
  • 03-05 发布

职位描述

Responsibilities: This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbant is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities:Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practicesMaintain and manage a project plan including resource forecasting Coordinate the activities of a global programming team that includes outsource provider staff Membership on departmental strategic initiative teamsDemonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentorAbility and interest to work across cultures and geographiesAbility to complete statistical programming deliverables through the use of global outsource partner programming staff Experience developing and managing a project plan using Microsoft Project or similar package Active in professional societiesExperience in process improvement Education and Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment Department Required Skills and Experience: · Effective interpersonal skills and ability to negotiate and collaborate effectively · Effective written, oral, and presentation skills · Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) · A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders Position Specific Required Skills and Experience: · Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise · Designs and develops complex programming algorithms · Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts · Familiarity with clinical data management concepts · Experience in CDISC and ADaM standards · Experience ensuring process compliance and deliverable quality · Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices · Ability to anticipate stakeholder requirements 职能类别: 临床数据分析员

联系方式

上海市徐汇区古美路1582号总部园二区A栋

公司信息

今天的默沙东正致力于为全世界带来健康的福音。我们为全球140多个国家提供药物、疫苗、生物制剂、健康消费品和动物保健产品,并与客户一起提供创新的健康解决方案。同时,我们还致力于通过各种意义深远的项目向需要帮助的人们捐赠和提供产品,从而扩展人们进入医疗卫生的途径。默沙东,健康是福。 默沙东中国的总部设在上海,目前中国大陆地区共有10个分公司和3座工厂,分别在上海,杭州和南京。员工总人数超过5100人。 目前,我们在中国提供涵盖心血管、抗感染、***健康、女性健康、骨科、疼痛、皮肤、呼吸、专科药品、辅助生殖、疫苗等领域的46种人用药品。默沙东在中国建有三座工厂,拥有技术水平领先全球的生产设施,一流的环境标、优秀的生产工人以及高水平的管理能力,符合中国药品生产质量管理规范(gmp标准)。我们还向中国市场提供46种动物健康产品,用以预防、治疗和控制家禽家畜以及宠物的疾病。 “我们应当永远铭记,药物是为人类而生产,不是为追求利润而制造的。只要我们坚守这一信念,利润必将随之而来。仅仅发明了一种新药,并非已经大功告成,我们还要探索有效途径,使默沙东的***科研成果,能够造福于全人类。” 乔治默克 一九五零年十二月一日 我们的事业是救治人类生命、提高生活质量,同时改善动物健康 我们坚持最高的道德与诚信标准 我们致力于不断提高科学研究水平,以改善人类与动物健康、提高生活质量为己任 我们希望的利润,全部来源于满足客户需求,并用于造福社会 我们相信公司的成功取决于员工的诚信、知识、想象力、技能、多元化以及团队精神 员工是默沙东最宝贵的财富之一。我们坚信,企业的成功归功于每一位员工的诚信、学识、敬业度和责任感。在中国,默沙东注重通过推行完备的人才管理体系,不断提升员工积极性和工作绩效,使他们能够充分发挥才能,并享受工作带来的成就感。 广纳良才 —— 寻找、吸引拥有丰富技能和正确职业态度的***人才 激 情 —— 创建独到的企业文化,让每一位员工充满激情,并且乐于分享企业的价值观和目标 发 展 —— 创建一种持续学习的环境,让每位员工做到更好 激 励 —— 对员工做出的贡献进行奖励

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