*Clinical Statistical Programmer - Ridgefield, CT -6+ months Contract*

Ridgefield, CT.

long term contract opportunity for a Statistical Programmer  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

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

Regards
Rachel Lian
Technical Recruiter
Desk No :201-855-4204 IT Brainiac Inc-
Princeton Forrestal Village
116 Village Blvd, Suite 200
Princeton - New Jersey 08540
[email protected] | Gmail:[email protected]
www.itbrainiac.com
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