Date:         Tue, 1 Dec 2009 02:01:11 -0800
Reply-To:     renxue <zijun2000@GMAIL.COM>
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From:         renxue <zijun2000@GMAIL.COM>
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On Dec 1, 9:31Â am, employee seeking <sarahma8...@gmail.com> wrote:
> Global CROä¸ æµ·è¯šè�˜Sr. Statistical Programmer
>
> 有兴趣的朋��以通过邮件与我�系 yujie...@excel-cro.com
>
> JOB DESCRIPTION FOR SENIOR STATISTICAL PROGRAMMER
> 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 SAS 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

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