clinical programmer(45-60万)

职位摘要

行业类型

生物制药

招聘人数

1

职位性质

全职

工作地点

上海

薪酬范围

45-60万

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我司正在为某德国知名制药公司招聘以下职位:clinical programmer
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职位概要 Job Highlights:

外资制药公司团队在扩

职责描述 Key Accountabilities:

Senior Statistical Programmer
Job Description
As a TPROG, utilize the company’s SOPs and guidelines, the TPROG and trial and project documentation to support the programming requirements of the Medical Quality Review Plan (MQRP), the Trial Statistical Analyses Plan (TSAP) and other supporting reports for trials of Phase I – IV. Gain specific knowledge about the clinical data collected for the trial. Attend trial meetings as necessary (e.g. Trial Preparation Meeting, Medical Quality Review Meeting, Blinded Report Planning Meetings). Communicate with other trial team members as needed. Keep management abreast of critical process issues, resource shortages and changes in timelines. Keep tracking systems current.
As a PPROG, provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals. Perform validation activities to ensure the quality of the submission. Keep abreast of international data standards (e.g. CDISC) and supply programming support to the project team to accomplish this requirement from the regulatory authorities.
Review and provide feedback to the trial or project statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs. Author or co-author the Analysis Data Set (ADS) specification with the statistician. Challenge the Technical TSAP and PSAP to ensure the most standardised and efficient processes can be used for its implementation. Ensure programming issues are resolved and specifications are kept updated in the SAP. Communicate and collaborate with the CRO programmer when any part of the programming is outsourced.
Transform specifications in the Project and Trial Statistical Analyses Plans (P/TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods; implementation of tables as specified in the MQR plan. Reviews the TLFs across the displays for consistency prior to review by the statistician.
Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid the department`s overall efficiency.
The PPROG develops a project programming strategy with the PSTAT and PDM, involving the trial teams as well. Define critical steps and decisions to be made to enable timely reporting in phase III on trial and project level. Implement project programs as much as possible and enable usage across trials.
Communicate and collaborate with the CRO programmer when part of the trial programming or double programming is outsourced, providing any necessary oversight.

职能需求 Competence Profile:

Senior Statistical Programmer
Job Description
As a TPROG, utilize the company’s SOPs and guidelines, the TPROG and trial and project documentation to support the programming requirements of the Medical Quality Review Plan (MQRP), the Trial Statistical Analyses Plan (TSAP) and other supporting reports for trials of Phase I – IV. Gain specific knowledge about the clinical data collected for the trial. Attend trial meetings as necessary (e.g. Trial Preparation Meeting, Medical Quality Review Meeting, Blinded Report Planning Meetings). Communicate with other trial team members as needed. Keep management abreast of critical process issues, resource shortages and changes in timelines. Keep tracking systems current.
As a PPROG, provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals. Perform validation activities to ensure the quality of the submission. Keep abreast of international data standards (e.g. CDISC) and supply programming support to the project team to accomplish this requirement from the regulatory authorities.
Review and provide feedback to the trial or project statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs. Author or co-author the Analysis Data Set (ADS) specification with the statistician. Challenge the Technical TSAP and PSAP to ensure the most standardised and efficient processes can be used for its implementation. Ensure programming issues are resolved and specifications are kept updated in the SAP. Communicate and collaborate with the CRO programmer when any part of the programming is outsourced.
Transform specifications in the Project and Trial Statistical Analyses Plans (P/TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods; implementation of tables as specified in the MQR plan. Reviews the TLFs across the displays for consistency prior to review by the statistician.
Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid the department`s overall efficiency.
The PPROG develops a project programming strategy with the PSTAT and PDM, involving the trial teams as well. Define critical steps and decisions to be made to enable timely reporting in phase III on trial and project level. Implement project programs as much as possible and enable usage across trials.
Communicate and collaborate with the CRO programmer when part of the trial programming or double programming is outsourced, providing any necessary oversight.

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