高级SAS编程经理-药物临床试验招聘_恒瑞医药-上海盛迪医药有限公司最新招聘信息-猎才医药网

职位描述

职位描述： Position Title: Senior Manager of SAS ProgrammingDepartment: Statistics / SAS ProgrammingJOB PURPOSESummarizes the job’s purpose or role and why it exists in the organizationSAS Programming Team in the department of Statistics of Hengrui R&D Center provides clinical programming support for various clinical studies and contributes to the development of departmental standards. Senior Manager of SAS Programming is accountable for programming team deliverables for the assigned clinical projects. This role is that of a programming lead who plans and provides oversight of SAS programming activities (e.g., development, verification and documentation) in support of clinical trial reporting and submissions.NATURE & SCOPEa) Organization StructureReport to:Head of Statistical ProgrammingNumber of Subordinates:TBDb) Key Working RelationsCommunicates with statistician and medical manager to fully understand analysis requirements for assigned clinical projects, leads the programming team to perform all SAS programming tasks with high quality in the agreed timeline, and works closely with data management to assure data quality, sometimes needs to interact with project/study manager on periodic trial management reports.JOB REQUIREMENTSAcademic / Professional Qualification- Minimum of a Bachelor’s degree in Statistics, Mathematics, Computer Science, Pharmaceuticals Sciences, Life Sciences, Public Health or other related areas. Master's Degree is preferred.- In-depth knowledge of SAS programming, statistics, clinical drug development process and regulatory requirements related to the role.Technical / Skills Training- In-depth knowledge of Base SAS, SAS/STAT, SAS Graph, SAS SQL and SAS Macro Language. SAS Certification is preferred, not required.- Basic knowledge to use Windows Operating System, and Microsoft Office (Word, Excel, PowerPoint and Outlook). Knowledge of Visual Basic, Java, Python or Perl programming language is preferred.- Effective communication skills and ability to establish and maintain effective working relationships with study team members. Being fluent in spoken and written English.- Thorough understanding of relational database components and theory.- Solid analytical and problem solving skills paired with strong attention to detail.- Must be a motivated, self-directed learner with a passion and drive for technology.- Ability to work under pressure and manage multiple projects simultaneously.Working Experience- Minimum of 7 years of proven experience in SAS programming. Pharmaceutical/Clinical trial experience is required.- Must have at least 2 years of experience of mentoring junior programmers.- In-depth knowledge of analysis requirements for endpoints in multiple therapeutic areas (TAs), oncology TA experience is highly desirable.- Experience working with external vendors/CROs is desired.- Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH-GCP etc.)- Fully accountable for the programming work.DUTIES & RESPONSIBILITESKey Tasks- Participates in review of protocol, statistical analysis plan (SAP), data integrity plan (DIP), data management plan (DMP) and case report form (CRF).- Participates in creation of programming documents including list of tables, mock tables, analysis specifications, dataset specifications and other related documents, and ensures all programming-related files are in the appropriate location on the company server.- Is accountable for the production of high-quality, on-time statistical programming deliverables (such as datasets and tables/listings/figures (TLFs)) for either outsourced or insourced clinical studies and development programs.- Works with data management to perform data quality checks.- Ensures clear and timely communications with study team members.- Ensures all programming activities following regulatory requirements and company SOPs.- Mentors new hires or provide training to SAS programmers.- Participates in the development and implementation of programming tools for data analysis and reporting.- Contributes to development of programming related SOPs.- Provides regular oversight of statistical programming work outsourced to programming vendors/CROs and acts as a liaison between the vendor/CRO and the Hengrui Biostatistics and Programming function. 职能类别：临床数据分析员医药技术研发管理人员

公司信息

江苏恒瑞医药股份有限公司始建于1970年，2000年在上海证券交易所上市，股票代码600276，是国内最大的抗肿瘤药和手术用药的研究和生产基地，国内最具创新能力的大型制药企业之一。公司先后被评为“全国医药系统先进集体”、“国家重点高新技术企业”，国家火炬计划新医药研究开发及产业化基地的骨干企业之一，“国家863计划成果产业化基地”，连续多年被国家统计局列为全国化学制药行业十佳效益企业；公司是国家“重大新药创制”专项创新药孵化器基地，是“中国抗肿瘤药物技术创新产学研联盟”的牵头单位；2011年，公司组建的国家靶向药物工程技术研究中心成为江苏省医药企业建立的第一家***工程技术中心；公司位列医药上市企业最具竞争力前三。2013年，公司实现营业收入62.03亿元。恒瑞医药本着“诚实守信质量第一”的经营原则，致力于抗肿瘤药、手术用药、造影剂、心血管药及抗感染药等领域的创新发展并逐步形成品牌优势。公司是国内首次通过国家新版GMP认证的制药企业之一，同时也是国内第一家注射剂获准在欧美上市销售的制药企业，在中国制药发展史上具有里程碑的意义。目前公司已有3个注射剂、2个固体制剂、5个原料药通过美国FDA和欧盟认证。在市场竞争的实践中，恒瑞医药坚持以科技创新为动力，致力于打造企业的核心竞争力。为此，公司在美国、上海、成都和连云港建有四大研究中心和一个临床医学部，拥有各类高层次专业技术人员1200余名，其中有500多名博士、硕士及海归人士，有4人被列入国家“千人计划”，7人被列入“江苏省高层次创新创业人才引进计划”。公司建立了***企业技术中心和博士后科研工作站。2011年9月，公司糖尿病科研团队在江苏省科技创新团队评选中名列第一。近年来，公司先后承担了4项国家863计划重大科技专项项目、23个项目列入国家“重大新药创制”专项，12项国家火炬计划项目，7项国家星火计划项目，23项***重点新产品项目及数十项省级科技攻关项目。公司共申请了近200项发明专利，其中97项PCT专利，有1个创新药艾瑞昔布已获批上市，2个创新药已申报生产，另有9个创新药处于不同的临床阶段。恒心致远，瑞颐人生。恒瑞医药一直秉承“科研为本，创造健康生活”的理念，以建设中国人的跨国制药集团为总体目标，拼搏进取、勇于创新，不断实现企业发展的新跨越和新突破。上海盛迪医药有限公司是江苏恒瑞医药有限公司的全资子公司。公司位于上海浦东张江高科技园区，注册成本2.5亿元，占地面积41000平方米，设有恒瑞新药研发、临床研究、专利注册、医学事务及产品市场管理等核心部门。公司将坚持创新与国际化发展战略，全力打造成为恒瑞医药的创新研发中心。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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