职位描述

职位描述： POSITION SUMMARY 职位概要 Supervisor / Manager 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 / Manager 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 / Manager 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 KEY RESULT AREAS 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 Shanghai 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 Head of 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 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 ESSENTIAL REQUIREMENTS 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 职能类别： 临床数据分析员

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