[b:1b5ry05y]Position Description[/b:1b5ry05y]
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
Develops SAS programs to produce data listings and Case Report Form Tabulations (CRT) as by domain or by subject
Builds standard tabulation datasets according to certain industry standard or the client’s requirements
Creates derived or analysis datasets according to certain industry standard or the client’s requirements based on the statistical analysis plan
Reviews the standard tabulation datasets and/or analysis dataset development specifications and SAS programs created by other Statistical Programmer(s)
Develops SAS programs to implement statistical analyses and generate tables, listings and figures as specified in the statistical analysis plans
Performs validation of and quality assurance aspects of all SAS programming activities
Supports for regulatory submission (e.g. NDA and PMA) including submission datasets preparation
Develops SAS programs for other needs
Represents SAS programming team at project team meetings and provides updates to project team on status of tasks
Communicates with project team members such as Project Biostatistician, Data Manager, and Project Manager regarding project issues
Communicates with client regarding SAS programming issues
Ensures integrity of all systems by preserving security and following change control procedures
Participates in department level applications such as SAS Macro Library Development
Consults on other statistical programming tasks, such as support for CRF design, database development, data validation plan and blinded data review
Consults on SAS program design strategies and provides technical support to programming team
Mentors and trains low level biostatisticians and new colleagues
Performs other duties assigned by supervisor
Qualifications
Bachelor degree in a scientific or technical area (statistics or related subjects is preferred); An advanced scientific degree is desirable
Knowledge of programming methodology; a high degree of skills in the management and resolution of SAS programming issues
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
Experience with the CDISC data standards and clinical database setup is preferred
Experience of international drug development in a multicultural environment is a plus
Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality
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
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
Excellent communication and interpersonal skills
Able to make effective presentations in public settings
Proficient working in a PC/Windows environment
A good command of English language if one’s native language is not English作者: shiyiming 时间: 2012-8-18 16:39 标题: Re: 国内最大CRO公司，诚聘Sr. Statistical Programmer kankan