• 5-7年经验
  • 本科
  • 招1人
  • 02-22 发布
  • 五险一金
  • 绩效奖金
  • 定期体检

职位描述

KEY ACCOUNTABILITIES The Statistician/Senior statistician develops or assists in the development of protocol designs, data analysis and reporting, and regulatory submission in collaboration with internal clinical study team and external stakeholders including business partners, CROs. The Statistician/Senior Statistician is accountable to: Operate in collaboration with study personnel to provide input to study protocol, perform sample size calculation, develop randomization schedule, write/review Reporting Analysis Plan, and write/review Statistical Analysis Report Assist with or be responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations Respond to statistical queries from other functional areas (e.g. medical, regulatory) and to interact with regulators as required.Collaborate with data management in the planning and implementation of data quality assurance plans.Provide tailored statistics education to less experienced statisticians or other groups if requiredParticipate in peer-review of work products from other statistical colleagues.Oversee the process and quality of statistical work contracted out to a CRO or research collaboratorPerform statistical programming if required Complexity: Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology Ability to negotiate and strategically influence other team members Specialised Knowledge: Knowledge of statistical theories and application Knowledge of clinical trial design elements and potential issuesKnowledge of statistical tools such as SAS, nQuery, PASS, EastKnowledge of Industry SOPs and regulatory requirements relating to statistics and data quality Minimum Requirements: Educated to at least master level in Statistics, Math or equivalent field of studyAt least 3-4 years experience in a multinational pharmaceutical company or Clinical Research Organization (CRO) as a biostatisticianProficient in the SAS programming languagePositive working attitude Preferred Requirements: Experience in early phase drug development, especially in oncology areaApplication of advanced theory and techniques in clinical development Self-management skills with a focus on deliverables 职能类别: 临床数据分析员 关键字: Statistician

联系方式

张江高科技园区哈雷路917弄4号楼

公司信息

和记黄埔医药(上海)有限公司(和记黄埔医药)是一家由香港和记黄埔有限公司(和黄)全资投资的医药研发企业。和黄成立于十九世纪,是香港著名的跨国公司,现已成为全球500强企业之一。 和记黄埔医药2002年9月成立,位于上海张江高科技园区,公司致力于为全球市场开发创新药物。和记黄埔医药拥有一套完整的药物研发体系和一流的研发平台。公司的高级管理层主要来自美国的世界知名医药及生物科技公司,拥有丰富的新药研发管理经验。在短短几年中,公司在癌症和自身免疫性疾病领域,开发了多个临床前和进入临床研究阶段的创新药物。公司现有两个创新药物在美国、欧洲和澳大利亚进行临床实验,同时还有多个项目正在中国处于临床前及临床开发阶段。 和记黄埔医药通过将世界一流的研发经验、技术平台与中国的资源相结合, 开发出高质量的临床候选药物,并将新药项目快速推入早期临床开发。和记黄埔医药通过多种研发途径来达到最优的产出,包括来自合成小分子化合物、半合成天然产物以及植物药的创新药物。成立至今,和记黄埔医药已与世界知名医药公司在多种疾病领域内建立了广泛的战略合作。 和记黄埔医药为员工提供有竞争力的薪资福利、以人为本的工作环境和良好的职业发展机会。我们期待敢于挑战的优秀人才加入我们的团队。

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