Hi Business Partners,
Hope you are doing great!

Looking for * SaaS Clinical Data Trials at Ridgefield, CT - Long Term
- *Please
share resumes to [email protected]

*Please not that these are Clinical not Financial in nature.*

*Candidates that have a background working as Financial Stat Developers are
not going to be a match.*

*Statistical Programmer* to join our client located in* Ridgefield, CT*.

*Job Responsibilities:*
·         Utilizes 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)
·         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
·         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
·         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
·         Provide support for the electronic submission to regulatory
agencies worldwide
·         Perform validation activities to ensure the quality of the
electronic submission
·         Establish project and substance databases following the rules of
good data base structure and data base integrity
·         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

*Job Qualifications:*
·         MS Statistics/BS Computer Science or Math
·         1-3 years experience supporting clinical trials


-- 
*Thanks & Regards*
*Lucky Pawar*
Sr Technical Recruiter
*Integrated Technology Strategies, Inc.*
Ph: 856-677-3043
[email protected] | www.itstrategiesinc.com
Yahoo/Gtalk IM : laxmikanthpawar

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