*HI PLEASE SEND ME YOUR UPDATED RESUMES TO [email protected]
<[email protected]> OR call me on 908-485-6432*


This is Vijay from Global Data Mart, Inc, please let me know if you are
interested and available for the below position. I would appreciate if you
can refer someone for this position.



*Title               :  SAS Programmers*

*Location        : Boehringer - Inglheim Ridgefield, CT*

*Duration       : 12 - 24  Months*

*Job Description: *

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." CDISC Exp

*Thanks*

P.Vijay

Global Data Mart, Inc.

5001 Hadley Rd, Suite 205, South Plain Field, NJ 07080.

Direct # 908-485-6432, Fax:732-623-9039.

Email:[email protected]

www.globaldatamart.com

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