- 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 Statistical programming manger is responsible for hiring, managing, developing statistical programmers and leading the development of company level programming system and tools. The Programming Manager is accountable to: Participate in the development of department standard operating procedures and guidelines, conduct training and evaluate staffing needs. Direct and coordinate statistical programming activities and assign staff to project teams. Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching Lead statistical programming activities at project level. Co-ordinate activities of all programmers either internally or externally assigned to the study/studies. Make statistical programming recommendations at study level. Review eCRF, discuss data structures and review activities as member of the Data Review Team. Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.Develop company SAS macros and utilities. Complexity:Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology Knowledge of statistical methodology Specialized Knowledge: Extensive programming experience in SAS including Data step, Macros, Statistical procedures, and Output delivery system Good knowledge of CDISC standards including: Study Data Tabulation Model (SDTM)Analysis Data Model (ADaM)Clinical Data Acquisition Standards Harmonization (CDASH) Minimum Requirements: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related fields is requiredAt least 6 years’ experience in pharmaceutical company or Clinical Research Organization (CRO) as statistical programmerPositive working attitude Preferred Requirements: Working experience in oncology projectsSelf-management skills with a focus on deliverablesProject management experience 职能类别: 临床数据分析员
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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