长沙招聘

Supervisor of Clinical Programming in the Clinical Programming and Writing (CPW) Group of China R&D Center (CRDC) is responsible for leading and providing management oversight of clinical programming support for various Pfizer global and regional clinical studies. The Supervisor leads and supervises a group of clinical programmers to work closely with biostatisticians to implement analyses as specified in statistical analysis plans, table shells, and programming requirement documents, in order to ensure all analysis and programming tasks are completed within the required time and quality goals. The Supervisor also proactively seeks and implements innovative ways to improve the efficiency and quality of work within the clinical programming function and will provide project management of the multiple tasks.

They also perform the responsibilities of clinical program for the studies, including but not limit to

· extracting data from databases to produce tables, graphs, analyses, and data listings based on clinical data, either for regulatory submission and reporting purposes for new drug application or for marketing support.

· providing input and review for activities of other statistics and clinical programming personnel, e.g. the review of Case Report Forms, protocols, statistical analysis plans, table shells, programming requirement documents, and databases in the future

· using SAS programming language, and following standardized quality control procedures for the development, testing, and implementation of the programs

· working with Report Publishing Group to coordinate inclusion of components into clinical study reports

Reports to: Clinical Programming Lead, Wuhan

Department: Wuhan CPW, CRDC

Location: Wuhan

Supervisory Responsibility:

· Set up clear expectations on project deliverables and commitments. Ensure timely communication with all stakeholders

· Make proper work arrangement and task assignment among clinical prgrammers to achieve timely and quality project delivery

· Regular liaison with Wuhan Group Lead of CPW Department to proactively plan and assess workload and priority activities and status of assigned tasks and projects

· Maintain and enhance staff motivation and morale to ensure retention of high performers

· Supervise team work and provide training plans for new staff and support existing staff develop their own training and individual development plans

Functional Support:

· Provide technical expertise and perform activities in support of reporting data from clinical trials

· Design and plan statistical algorithms and code in conformance with a globally aligned Systems Development Life Cycle (SDLC) and programming standards and within the applicable regulatory guidelines for the assigned clinical development programs for worldwide filings

· Ensure that all programs, outputs and documentation are consistent with relevant ICH (eg. E6, E9, E10 etc) requirements and are conducted in compliance with relevant SOPs

· Be accountable for implementation of statistical analyses, programmed outputs, and tables listings and graphs for integrated scientific reports for clinical trial results and support for publication activities, for assigned projects

· Provide input into the design and development of project plans; in providing planning, development and delivery of analyses, (tables, listings and graphs), for use in scientific reports, clinical trial results, publications, regulatory response and commercialization

· Implement global strategies, initiatives, processes, and standards to ensure speed and quality of fully integrated global data analyses on individual studies, submissions and other reporting of aggregated data

· Ensure clear and timely communication with colleagues to enable improvements to be implemented during the study and also

· Liaise regularly with Lead of Wuhan CPW Department or other business owner to assess workload and priority activities and status of assigned tasks and projects

· Ensure timely delivery of outputs to meet study timelines and quality expectations

· Work with Head or Group leads of CPW Department or other CRDC management (if necessary) to give input to project plans and to implement resource strategies to achieve CRDC goals

· Provide regular feedback as to the efficiency and effectiveness of current procedures/jobs

Personal Development:

· Attend and actively participate in personal development courses as required

· Attend Pfizer in house training and workshops

· Develop and maintain competence in SAS programming and other related tools

Financial

· Nil

Staffing

· The Supervisor supervises and coordinates clinical programming staff or contractors in analysis and reporting activities of data from one or more studies

Policy/Procedure

· Liaison of reviewing and developing all Clinical Programming and relevant policies and procedures, and responsibility for compliance of the department with all corporate standards, policies and procedures.

Education

· At least bachelor degree or equivalent in statistics, computer science, or a mathematical science

· Master's Degree preferred

Experience

· Minimum three years proven experience with SAS programming in clinical development

· Previous experience in clinical programming managerial role or equivalent is desirable

· Some clinical development and business experience in order to have an understanding of the processes associated with clinical and regulatory operations

· Experience supporting regulatory submissions

· Extensive knowledge of computer systems, operating systems and analysis and reporting environments used in the support of clinical programs and the development of software via structured SDLC.

Key Competencies

· Strong understanding of the current technologies and global Analysis and Reporting environments to utilize them for efficient delivery of programming outputs

· Expertise in the SAS programming language

· Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization

· Knowledge of Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)

· Ability to write clear, well documented, and standardized computer programs

· A readiness and ability to work to pre-defined programming standards

· Strong project management and analytical skills

· Able to work on multiple projects simultaneously

· Demonstrated platform skills. Experience in presenting to science and non-science audiences

· Capability to communicate effectively in English, both verbally and written

· May oversee team members and/or contractors

· Must be accurate and have an excellent attention to detail and a quality control approach to work.

· Ability to work effectively in a multi-cultural context and in a matrix organization

· Utilizes and shares innovative approaches to build and maintain a competitive advantage

· Looks for opportunities for collaboration and acts upon them

· Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards.

· Contributes to a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。