Principal Statistical Programmer
科文斯医药研发(北京)有限公司上海分公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2012-11-02
- 工作地点:北京
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:英语精通
- 职位月薪:20000-29999
- 职位类别:临床数据分析员 数据库工程师/管理员
职位描述
¨ Act as the Lead Programmer and with necessary guidance act as the Biometrics Project Manager for assigned projects
¨ Lead programming efforts for the preparation of electronic submissions.
¨ Ensure quality of personal work and the work of the team when acting as a Lead Programmer or Biometrics Project Manager.
¨ Interact with project team members in related disciplines e.g. Clinical Data Management, Clinical and Biostatistics.
¨ Assume team member responsibilities, including representing Statistical Programming at internal project team meetings, client meetings and audits.
¨ With sufficient experience may support the activities of senior Statistical Programming staff by providing input into time and cost estimates and presentations to clients.
¨ Advise Senior Statistical Programming staff of changes in scope of projects to enable the timely development of change orders.
¨ With sufficient experience may take an overview of nominated projects, providing ongoing supervision, advice and consultation to the Lead Programmers and the rest of the programming team to ensure timely and efficient completion of these projects.
¨ Prioritize personal workload to meet specified completion dates and perform work with minimal supervision.
¨ Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment.
¨ Provide ongoing training and mentoring within Statistical Programming to ensure thorough knowledge of the processes used and the ongoing technical development.
¨ Provide feedback to management on the development potential of staff to assist in staff development.
¨ Perform interview and selection of potential candidates.
¨ Demonstrate excellent problem solving skills, a proactive approach and a willingness to take decisions on a regular basis.
¨ Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines.
¨ Prepare and review Programming Plans.
¨ Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. data validation guidelines).
¨ Review and interpret Report and Analysis Plans and provide comments for assigned projects.
¨ Technical planning (which includes overseeing the set-up of the key macros/SAS programs) for multi-protocol projects (e.g., appropriate documentation required by the project).
¨ Develop and review SAS programs and output for the management of clinical trial data, the tabulation of data, preparation of patient data listings, graphical output, creation of derived datasets and statistical analysis of data as specified in the Statistical or Report Analysis Plans.
¨ Develop SAS programs for ad hoc tables and listings. Write, modify, and maintain programs that produce diagnostics and listing for data review in support of Data Management
¨ Carry out electronic data transfer (both incoming and outgoing). Develop and review programs to ensure the data transfer has been produced to specification.
¨ Design and set-up utilities/SAS based systems to assist and facilitate Clinical Data Management activities.
¨ Review draft and final production runs for projects to ensure quality and consistency.
¨ Work on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity.
¨ Responsibility for ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
¨ Provide input into assessments of resource requirements on a regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.
¨ With sufficient experience may perform ongoing review of hours for projects assigned to, ensure that all issues are highlighted and resolved as quickly as possible and ensure all non-contract tasks are identified, tracked and included in change order forms.
¨ Encourage and participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually improved.
¨ Maintain awareness of new developments in programming techniques and IT which may be applied to the management and reporting of clinical trial data.
¨ Acquire knowledge of other aspects of the work of a Manager, Statistical Programming under the supervision of the senior Statistical Programming staff.
¨ Perform other duties as assigned by senior Statistical Programming staff.
You can refer and submit CV by system or email to calvin.xu@covance.com
You are strongly encouraged to visit our recruitment website as http://careers.covance.cn/
公司介绍
Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/
联系方式
- 公司网站:http://www.covance.com
- Email:calvin.xu@covance.com
- 公司地址:上海市黄埔区西藏中路268号来福士广场1806室
- 邮政编码:200001
- 联系人:Vicky Qu