发帖
雷达卡
有兴趣者请联系 yujie.ma@excel-cro.com
Position Description
Performs all SAS programming tasks for a given clinical study or studies involving drugs, biologics and medical devices, acts as the primary point of contact for SAS programming activities for a given clinical study or studies and ensures adherence to guidelines, methodology and SOPs for software development in accordance with FDA, ICH, GCP and SDLC methodology; and provides technical support to the programming team.
Responsibilities
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Develops SAS programs to produce data listings and Case Report Form Tabulations (CRT) as by domain or by subject
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Builds standard tabulation datasets according to certain industry standard or the client’s requirements
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Creates derived or analysis datasets according to certain industry standard or the client’s requirements based on the statistical analysis plan
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Reviews the standard tabulation datasets and/or analysis dataset development specifications and SAS programs created by other Statistical Programmer(s)
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Develops SAS programs to implement statistical analyses and generate tables, listings and figures as specified in the statistical analysis plans
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Performs validation of and quality assurance aspects of all SAS programming activities
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Supports for regulatory submission (e.g. NDA and PMA) including submission datasets preparation
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Develops SAS programs for other needs
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Represents SAS programming team at project team meetings and provides updates to project team on status of tasks
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Communicates with project team members such as Project Biostatistician, Data Manager,
and Project Manager regarding project issues
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Communicates with client regarding SAS programming issues
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Ensures integrity of all systems by preserving security and following change control procedures
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Participates in department level applications such as SAS Macro Library Development
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Consults on other statistical programming tasks, such as support for CRF design, database development, data validation plan and blinded data review
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Consults on SAS program design strategies and provides technical support to programming team
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Mentors and trains low level biostatisticians and new colleagues
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Performs other duties assigned by supervisor
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Qualifications
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Bachelor degree in a scientific or technical area (statistics or related subjects is preferred); An advanced scientific degree is desirable
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Knowledge of programming methodology; a high degree of skills in the management and resolution of SAS programming issues
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At least 3 years (for bachelor) or 2 years (for master or above) experience with Base SAS (data step programming), SAS/SQL, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/ACCESS and SAS/STAT. ISS/ISE experience is a plus
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Experience with the CDISC data standards and clinical database setup is preferred
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Experience of international drug development in a multicultural environment is a plus
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Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality
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Demonstration of ethical leadership skills and exhibit high moral character so as to foster respect for ethnic and religious diversity and support equal opportunity for all employees based on demonstrated ability and to exhibit a high degree of skills in the management and resolution of conflict
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Knowledgeable in all aspects of the drug agencies (e.g. FDA) regulations and requirements governing the conduct of drug, biologic and device studies including, but not limited to, GCP and ICH requirements
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Excellent communication and interpersonal skills
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Able to make effective presentations in public settings
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Proficient working in a PC/Windows environment
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A good command of English language if one’s native language is not English
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