Dear Professionals,
Please have the below requirement and send me your consultant resumes ASAP
Please reply at   *dennis.h...@panzersolutions.com*
<dennis.h...@panzersolutions.com>




*Sr. Clinical Data / SAS ProgrammerRaleigh, NC6+ Months Contract*

**** Please only submit when you have worked on mulitple CDISC (10+) and
written Reviewers Guide with CDISC package. Previous SDTM/ADaM/XML
expereince required.*

We have looking for multiple Sr. Clinical Data/SAS Programmer,
Biostatistics and Programming report toBiostatistics Manager.

Sr. Programmer with a stable work history and very strong communication
skills for a leading Pharmaceutical product and development Companies
located in Wayne, PA or RTP, NC area. Sr. Programmer, also function as
resident
CDISC expert including, but not limited to guidance on mapping SDTM domains
and data sets and preparation of SDTM and ADaM files and XML defined
documents.  Market Rate, commensurate with education and work
experience. Multiple openings, one year (renewable) contract,
contract-to-perm.

*Notes: required *6+ years pharmaceutical industry Programming experience
with hands on experience on multiple CDISC project (10 or more studies).*

***6+ years clinical trials in pharma or CRO. In depth, hands-on experience
on multiple CDISC projects. Excellent communication skills***
All responsibilities from the Programmer position will be performed, in
addition to the following:
Sr. Programmer, also function as resident CDISC expert including, but not
limited to guidance on mapping SDTM domains and data sets and preparation
of SDTM and ADaM files and XML defined documents.

Part III - Principal Responsibilities
Create SAS datasets of clinical data from clinical databases; create status
and efficacy datasets; create project specific macros and formats; prepare
data to be sent to clients.
CDISC SDTM mapping specs/domains/datasets/aCRF/define.xml development and
SDTM data transfer operations on clinical studies to ensure client and
corporate goals are met, including quality, timelines, and budgetary

milestones.
Validate CDISC SDTM and ADaM domains/datasets/define.xml.
Run and create reports for validation of SDTM domains/datasets, ADaM
datasets and define documents as necessary.  Create Reviewer’s Guide with
explanation of all errors/warnings that will not be eliminated
programmatically.
Development, modification and/or production of programs to provide SDTM
domains/datasets of completed databases for transfer to clients.
Interact with client and/or third-party vendors regarding programming and
database development.
Provide help/guidance on Modules creation for structuring new forms and
field names within QDR and Export Datasets creation utilizing SAS; annotate
mock CRFs for studies performed with CDISC standards; validate master

template SAS export datasets against the latest CDISC standards.  Provide
help/guidance to QA on SAS export datasets validation.
Identify contract overages in a timely manner for change order process;
sustain client communication in this regard.
Develop and implement Standard Operating Procedures and Guidelines for all
aspects of CDISC SDTM programming and quality deliverables development.

Knowledge, Skills, and Competencies
Bachelor or Master degree required, Any statistics/biostatistics degree a
plus
6 to 10  years clinical trials in pharma or CRO. In depth SAS programming
knowledge.
Hands-on experience on multiple CDISC projects (10 more studies).
Written Reviewers Guide with CDISC package. SDTM/ADaM/XML Works
Familiarity with statistical methods used for biomedical/pharmaceutical
research required;
Experience with clinical trials or pharmaceutical industry experience
required;
Knowledge of current industry and regulatory submission practices, protocol
designs, and terminology.
Excellent communication skills

Thank you for your time and look forward to work with you.
___________________________________________________________
Thanks
Dennis Hall | Sr.Technical Recruiter
Panzer Solutions LLC
dennis.h...@panzersolutions.com
Direct: 203-652-1444 Ext 265

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