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Asso. II, Clinical Programming

Pfizer


Location:
Shanghai City, IL 61412
Date:
11/15/2017
2017-11-152017-12-16
Pfizer
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Job Details

POSITION SUMMARY







Clinical Programmers in the Clinical Programming and Writing (CPW) Group of China R&;D Center (CRDC) provide clinical programming support for various Pfizer global and regional clinical studies. They work closely with statisticians to implement analyses as specified in statistical analysis plans, table shells, and programming requirement documents. They are responsible for 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. They may also provide input and review for the 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. Clinical programmers work primarily in the SAS programming language, and follow standardized quality control procedures for the development, testing (including peer review), and implementation of their programs. They work closely with colleagues in the Report Publishing Group to coordinate inclusion of components into clinical study reports.







KEY RESULT AREAS







Perform activities and provide technical expertise 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 manager 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 manager 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 to manager.







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.







Education







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



Master Degree preferred







Experience







3 years relevant experience with SAS programming in clinical development



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



Basic knowledge to use 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 analytical skills.



Able to work on multiple projects simultaneously.



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



Demonstrated effective written communication skills



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



May oversee 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



Ability to work effectively 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.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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