北京招聘

Responsibility：
1. Perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies and integrated analysis, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data surveillance, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity.
2. Provide programming supports for submission and help submission team in quick turnaround in exploratory analysis and response to regulatory agencies. Responsivities include: create analysis dataset (including specifications) and TLFs to prepare submission, respond to agencies’ questions, perform ad-hoc analysis requested by clinical team, and provide programming supports in potential Oncology Drug Advisory Committee (ODAC).
3. Support programming project lead to oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning as the backup of the programming project lead, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, maintain all required study programming documentation required for Trial Master File (TMF).
4. Support building up DS compound specific programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: support developing, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standards, develop/validate sample programs to generate standard ADaM dataset and TLFs, and develop and maintain programming macros to effectively support internal data review and data surveillance.
Qualification：
1. Bachelor's degree from an accredited institution in a technical field such as computer science or mathematics; Master's degree in bio/statistics preferred.
2. one year or above relevant working experience, excellent fresh graduates can also be considered.
3. Advanced working knowledge of SAS programming language used in clinical trials programming.
Advanced working knowledge of CDISC ADaM, and extensive experiences of their implementation in clinical trials analysis.
Working knowledge of CDISC SDTM.
Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.
Having knowledge of drug development. Experiences of regulatory submission and supports are preferred.
Having solid background of applied statistics.
Solid knowledge of new advanced statistical methods using SAS and R is a plus.
Knowledge in database structures and set-up.

    第一三共集团是一家具有百余年历史的跨国制药企业，总部位于日本东京，全球约有1.5万名员工。在全球范围内专业从事各类医药产品的研究、开发、生产和经营的多元化制药集团。

    第一三共在中国已开展了三十多年的业务，我们提供的医药产品覆盖各治疗领域，抗感染治疗药-可乐必妥、高血压治疗药-傲坦和降血脂药-美百乐镇、止咳药-阿斯美、止痛药-乐松以及治疗前列腺肥大的优利福等药物，为广大的中国人民减除了病患。目前有员工近一千三百名，并在全国各级城市设有分支机构开展医药事业。第一三共（中国）投资有限公司作为第一三共在中国的地区总部,统一管理在华业务。第一三共制药（北京）有限公司和第一三共制药（上海）有限公司作为生产基地，生产的药品被广泛用于各个医疗领域。
    第一三共秉承作为与生命密切相关企业应有的高度伦理观和良好的社会意识开展各项业务，以此积极满足来自不断变化的多样化社会的要求，提升企业价值。我们严格按照GMP要求进行生产和质量控制，用专业的服务意识和奉献精神将最新的临床药品信息和治疗手段及时准确地传递给医务工作者，切实满足医疗需求，提供有用且值得信赖的高品质医药品和服务。

    Innovation、Integrity、Accountability是我们的源动力。
    第一三共始终坚持：激情创新。真情为您。　Passion for Innovation. Compassion for Patients.