Senior 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:2
- 工作经验:三年以上
- 学历要求:本科
- 职位类别:临床数据分析员
职位描述
Responsibility:
Act as the Lead Programmer 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.
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.
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.
Advise Senior Statistical Programming staff of changes in scope of projects to enable the timely development of change orders.
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.
Assist with interviewing and selection of potential candidates.
Demonstrate excellent problem solving skills, a proactive approach and a willingness to take decisions on a regular basis.
Acquire knowledge of other aspects of the work of a Principal Statistical Programmer under the supervision of the senior Statistical Programming staff.
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.
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).
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.
Prepare and review of 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).
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.
Review and interpret Report and Analysis Plans and provide comments for assigned projects.
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.
Responsibility for ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit
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.
Perform other duties as assigned by senior Statistical Programming staff.
Requirement:
BSc in a computing, life science, mathematical or Statistical subject.
Approximately 3.5 years experience in provision of programming support for clinical trial management and reporting, or equivalent experience.
Extensive experience and proven skills in the use of SAS within a clinical trials environment.
A good understanding of the fundamental principles of programming, program development and review.
Experience in the preparation and review of Programming Plans, study set-up and review of study specific documents, e.g. CRF and data validation guidelines. Extensive experience in the development and review of SAS programs for management and reporting of clinical trial data.
Extensive experience in the development and review of programs to perform electronic data transfer.
Knowledge in all aspects of clinical trials from initial study set-up to study completion.
Full knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.
An understanding of the job roles in programming, to be able to identify training and development needs, opportunities for optimizing staff utilization and employing the most efficient practices.
A good understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.
Excellent problem solving skills, a proactive approach and a willingness to take decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary.
Excellent organizational skills and the ability to delegate and prioritize work. Self motivation and ability to work independently with minimum direction.
Excellent time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work.
Good interpersonal skills and the ability to communicate appropriately with all levels of staff and confidently with other disciplines and external clients.
A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them..
A co-operative and team orientated approach.
Team leadership experience, as demonstrated by ability to organize and motivate project teams. Some general business awareness and an appreciation of the business needs of a CRO.
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