上海康德弘翼医学临床研究有限公司

岗位职责：

1.Design and plan statistical algorithms and code in conformance with a globally aligned Systems Development Life Cycle (SDLC) and programming standards, such as Pfizer clinical data standards, and are in compliance with relevant SOPs and the applicable regulatory guidelines for the assigned clinical development programs
参与设计并计划统计运算及代码编写，按照相关的SOP和其他适用的规则指南对分配的临床开发项目进行程序编写；
2. Ensure timely and quality programming documentation for inspection readiness
确保按时并保质保量完成程序的存档工作以备视察；
3. Provide input into the design and development of project plans: provide planning, development and delivery of analyses, (tables, listings and figures) for use in scientific reports, clinical trial results, publications, regulatory response and commercialization
参与设计并开发项目计划：提供用于科学报告，临床试验结果，出版物，监督管理应答和商品化过程中的所有分析，开发和交付计划（交付图，列表和表格）。
4. Deliver according to the overall protocol timeline and quality goals through matrix communication within the Study Team
按照试验方案既定时间表和质量目标进行交付。
5. Communicate effectively within the teams and functional lines
保持与组内成员以及职能线上的良好沟通。
6. Maintain responsibility and metrics on quality control process for CPW deliverables
对CPW交付结果保持高度的责任心。
7. Review and provides feedback on protocol, CRF, SAP and other study-related documents to ensure all programming requirements are met
对试验方案，CRF, SAP和其他试验相关的文档进行复核并提供反馈意见以确保满足所有程序编写的要求。
8. Contribute to the Study Reporting Plan (SRP) and related programming documentation to ensure programming completeness and accuracy
参与研究报告计划和相关的编写程序归档以确保程序编写的完整性和准确性
9. Perform hands-on programming activities (generation and QC of tables/listings/figures/datasets) and provides technical expertise to support data reporting for clinical trials
完成程序编写任务（完成图，列表，表格，数据集的生成）并为临床试验的数据报告提供技术支持。
10. Provide programming algorithm support as needed
提供程序编写运算的技术支持。
11. Produce PK/PD analysis data files and data presentations according to corresponding processes and standard (PK/PD Programmer)
生成药代和药效动力学分析数据文件并将根据相应的流程和标准数据呈现给相应的程序员。



任职要求：

1. Minimum of Bachelor’s Degree or equivalent in statistics, computer science, mathematical science or related discipline; Master’s Degree with CET-6 preferred
本科及以上学历，统计，计算机科学，数学或相关学科，硕士学历英语6级及以上者优先考虑。
2. Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
可以用英语跟本地的和全球的公司内部和外部人员进行有效并恰当沟通。
3. Knowledge of clinical development process including knowledge and understanding of the principles of GCP
熟悉临床开发流程包括了解GCP的基本原则。
4. Knowledge of clinical programming processes and principles, including software development/validation, QC and definitions of specs
了解临床程序编写的流程和基本原理，包括软件开发和验证，质量控制和参数的定义。
5. Knowledge of SAS and associated applications, including good coding practices
熟悉SAS及其相关应用，包括良好的编码规范。
6. Works independently. Receives instruction primarily on unusual situations
一般情况下能独立完成工作，特殊情况时可接受指导