Law

Please send resumes to praveen@addonusa.com

Location: Ridgefield, CT

Duration: 12 Months

--Job Description--

 1. Utilizes BI SOPs and guidelines, trial protocols, annotated case report forms, Oracle*Clinical study definitions, trial and project data handling rules and standards, and Statistical Analyses Plans in preparation for the programming of the Data Quality Review Plan (DQRP) and the safety and efficacy tables, listings and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated Analyses Data Sets (ADS).  Gains specific knowledge about the users' environment, data, software and hardware needs

 2. Produce well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting.

 3. Review the programming specifications and table mockups in the Trial/Project/Substance Statistical Analyses Plan (T/P/S/SAP) for completeness, correctness and adherence to sited department guidelines and SOPs.  Ensure all programming issues are resolved and updated in the T/P/S/SAP.   Ensure additional specifications once programming commences are properly documented.

 4. Transform specifications in the Trial/Project/Substance/ Statistical Analyses Plan (TSAP) into fully documented, validated 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 unable to use a standard macro that are well specified by the trial team; efficacy displays that require a moderate amount of applied statistics knowledge in order to produce a well documented validated efficacy program; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods. 

 5. Provide support for the electronic submission to regulatory agencies worldwide.  This may include the preparation of safety and efficacy data files, application programs, electronic documentation and user manual.  Performing validation activities to ensure the quality of the electronic submission. 

 6 Establish project and substance databases following the rules of good data base structure and data base integrity. The structure of the data base must support the execution of the standard safety macros.

 7 Provide fully documented, validated programs utilizing project or substance data bases in support of integrated reporting for regulatory agencies, Investigator Brochures (IB), Monitoring Committees, etc.  

 8     Help maintain libraries of fully documented and validated programs, macros and  procedures which can be reused by other programmers to aid in the efficiency for the department.

 Background:

1-3 years exp supporting clinical trials

 Educational requirements:

MS Statistics/BS Computer Science or Math

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Please do let me know if any one fits for this position

Thanks & Regards
Praveen Kumar

Addon Technologies
Email : praveen@addonusa.com
www.addonusa.com

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