发帖
雷达卡
Responsibility: 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 Database Programming at internal project team meetings and with support from senior Database Programming staff at client meetings. When acting as a Lead Programmer provide input into resource assessments for programming activities Advise Senior Database Programming staff of changes in scope of projects to enable the timely development of change orders. Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment. Assist with training, mentoring of Database Programmers under the supervision of senior Database Programming staff. Demonstrate good problem solving skills, a proactive approach and a willingness to take decisions, seeking advice from senior Database Programming staff to confirm decisions when necessary. Participate in the ongoing review of the processes used by the Database Programming group to ensure processes are continually improved. Acquire knowledge of other aspects of the work of a Senior Database Programmer under the supervision of the senior Database Programming staff. Perform other duties as assigned by senior Database Programming staff. Carry out all activities according to SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). With guidance and sufficient experience prepare and review of Programming Plans. Participate in the Database 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 as required for the management of clinical trial data, the tabulation of data, preparation of patient data listings, graphical output, creation of derived datasets. Develop SAS programs for ad hoc 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. 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. With sufficient experience assume the role of a Lead Programmer for assigned projects. Ensure the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. Prioritize personal workload to meet specified completion dates.
Requirements: BSc in a computing, life science, mathematical or Statistical subject A high computing content is considered to be beneficial, however proven computing skills are most important. Alternative academic qualifications or experience are assessed to ensure equivalent background. Approximately 5 years experience as Statistical Programmer, or equivalent experience. Demonstrated skills in the use of SAS. An understanding of the fundamental principles of programming, program development and review. Some experience in the preparation of Programming Plans, study set-up and review of study specific documents, e.g. CRF and data validation guidelines. Experience in the development and review of SAS programs for management and reporting of clinical trial data. Experience in the development and review of programs to perform electronic data transfer. A good understanding of clinical trials processes. Full knowledge and understanding of the processes and procedures used within Statistical Programming. A basic understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management. Good problem solving skills, a proactive approach and a willingness to take decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary. Good organizational skills and the ability to prioritize work. Self motivation and ability to work independently seeking direction when appropriate. Good time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work. Effective communication skills. A co-operative and team orientated approach. Some appreciation of the business needs of a CRO
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