天津招聘

主要职责：
1. Provides cross-program application support to Statistical Programmers, Biostatisticians, and Submission Specialists to facilitate the production of CSRs, integrated summaries, randomizations, validations, ad-hoc analyses, and eSubmission components
2. Develops and maintains reusable application code to speed production of Biostatistics deliverables
3. Produces analysis data sets, summary tables, data listings, and figures for clinical studies using appropriate programming as documented in the SAPs
4. Performs QC and QA activities for applications and as backup for CSR activities
5. Provides input on application programming standards and techniques
6. Maintains relationship with Clinical Data Management to improve data transfers, reporting, and other processes
7. Collaborates with biostatisticians and programmers to develop specifications and requirements
8. Attends SMT when needed

This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.
任职条件
？教育要求：Bachelor’s degree or above in Statistics discipline
？工作经验要求：5 years substantial and related experience in statistical analysis issues or programming
？岗位技能要求： Familiar with laws and regulations regarding to data management and statistical analysis in FDA, EMA and CFDA, familiar with the ICH guidelines, a solid basic knowledge of statistics, skilled use of SAS software, familiar with the process of data management, familiar with CDISC standard.

？品性要求：
1）Proactive and strong sense of responsibility;
2）Self-disciplined, able to work independently and to work under pressure;
3）High level of enthusiasm and good team work.
4）Good communication skills and patience;
5）Integrity, preciseness and honesty.

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。