（高级）生物统计经理-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： BACKGROUNDHENGRUI Medicine Clinical Statistics team is responsible for the development and implementation of innovative trial designs, statistical models, and data analysis for both oncology and non-oncology portfolio projects, is expected to set strategic direction for addressing statistical issues in regulatory submission and plays a leading role in interaction/communication with regulatory on statistical matters.NATURE & SCOPEFunctioned as a co-owner of a clinical study, Clinical Statistics team deliveries reports together with physician and clinical operation, provides trial design, CRF review, data analysis and interpretation and reports on all innovative pipeline interventional clinical studies in collaboration with TA clinical sciences physicians, serves as statistics line representative and is responsible for holding CRO/Partners accountable for high quality standards of their activities and deliverables.JOB REQUIREMENTS (* for manager, ** for senior manager)General:Good capability of learning with enthusiasm and keeping up with the latest methods & technologies for clinical trialsAbility to work under pressure.Academic / Professional QualificationEssentialMaster or PhD in statistics/biostatistics, mathematics, or other related data science majorsKnowledge of the technical and regulatory requirements related to the roleTechnical / Skill TrainingEssentialAbility to apply statistical expertise to complex problems, problem solving and quality focusGood communication skills and ability in building sound relationshipsGood collaboration with colleagues, working in a high efficient and cross-functional mannerDesirable*Knowledge of compound, disease and regulatory guidance including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesWorking ExperienceEssentialMinimum 2 years of multi-national industry experience as a clinical statisticianExperience of leading and directing a projectDesirable**Experience of regulatory interactions and/or submissions**Experience/knowledge of using CDISC/ADaMDUTIES & RESPONSIBILITIES (* for manager, ** for senior manager)Assist with protocol development, sample size calculation, protocol and case report form (CRF) reviewDevelop Statistical Analysis Plans, including statistical methodology, key statistical programming procedures, definition of derived variables, data-handling rules and mock-ups*Advise data management staff on database design, and be responsible for critical data and data quality reviewPrepare randomization specifications and verify randomization components (specification and schedule). Provide input into planning activities, including the preparation, distribution and access to the randomization and its unblindingExecute independent peer review or QC of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures & Patient Data Listings, statistical reports and Clinical Study Reports*Provide support for special committees, e.g., DMCs including input/review of charters and maintenance of appropriate blinding**Leadership on the product so that all work is carried out in compliance with HENGRUI standards and external regulations**Set up standards (and enforcing compliance) for statistical work within the productHold CRO/Partners accountable for the high quality standards of their deliverablesInvestigate and implement statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration*Provide consulting services in statistical field, which includes but not limited to study design interpretation, problem-solving in implementation, data- examination guidance and research-result explanation.**Understand the submission issues, having the ability to communicate with experts in CDE in an effective manner.*Provide statistical trainings to newcomers and other department colleagues 职能类别：临床数据分析员

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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