深圳招聘

In 3D Medicines, a Principal Statistical Programmer provides the programming leadership and serves as the key stakeholder to the project team. A Principal Statistical Programmer provides timely support to the project team on all programming matters according to the project strategies. The incumbent is to assist in providing guidance in implementing and executing the programming and project standards based on statistical analysis plan and company conventions. The evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical ad-hoc requests of senior management and regulatory agencies. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.

>Responsibilities:

1. Support and/or lead programmer for programming and QC of analysis datasets and TFL's following the industry standards or company requirements. Assist in the coordination of activities and communicate shifting timelines and milestones.
2. l  Provide programming leadership for regulatory submission related activities. Create, manage and maintain the programming specifications for the analysis datasets utilizing 3D Medicines tools and methodologies.
3. l  Support creation and validation of electronic submission requirements (i.e. annotated CRF, data export files, define documents).
4. l  Work in a multidisciplinary study/project team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, develop and provide department training for applications and standard tools developed by the department functions group.
5. l  Provide programming support for the manuscripts, publications and conference presentations.
6. l  Provide leadership in continuous improvement programming initiatives in the department.

Requirements:

1. Also acceptable – BS/MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health-related industry. SAS Certification desirable
2. Works independently exercise judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
3. Knowledge in the creation of current CDISC data structures.
4. Knowledge of SAS, (Base, Stat, Macro, graph) is required.
5. Strong SAS programming skills, preferably in a clinical data environment.
6. Strong understanding of relational database structure.
7. Experience with implementing standardization methodology.

思路迪（3DMed）2010年成立于上海，是最早在中国展开肿瘤精准医疗检测服务的公司之一，经过长期的耕耘发展，从集团公司分拆之后的思路迪诊断，已经是中国肿瘤精准诊断领域领军企业之一，目前在中国、美国和新加坡拥有超过800名员工。
目前，思路迪诊断已经构建了集成设备工程、电气、生命科学技术、材料学和数据分析为一体的综合性研发平台，具备实现精准诊断领域研发制造全自动化操作系统的能力。其拥有自主研发的封闭式全自动化NGS文库制备平台，以及前瞻创新的肿瘤早期诊断标志物（外泌体）开发平台，促成了基于这些平台的多个突破性辅助诊断和伴随诊断产品正在临床试验阶段或即将进入临床试验；公司传染病平台开发基于自动化和POCT化的产品服务，覆盖全球传染病诊疗网络。公司还拥有第三方医学检验所，其拥有行业权威的CAP/CLIA资质，所覆盖的精准诊断营销网络超过70%的核心三甲医院，服务对象超过800家医院，提供从肿瘤早期诊断到靶向治疗、免疫治疗、再到术后动态监测的精准医疗全程管理产品和服务。