*Title: Sr. Statistical Programmer/Analyst*

*Location: Fort Washington, PA*

*Client: FMDK *

*Position: 20*



Qualifications: The candidates should ideally possess the following
qualifications:

I.             Education and Experience. *BS/MS in statistics or related
science with 5+/4+ years of experience in the pharmaceutical industry*,
respectively.

II.            Skills:

a.            Hands-on skills in legacy data conversions to *CDISC SDTM
data sets*

i.              Annotated CRF with SDTM data set name and variable name,
generate bookmarks and hyperlinks as appropriate

ii.             Create SDTM specifications per CDISC SDTM Implementation
Guide

iii.            Develop and QC SDTM data sets with double programming

b.            *Good working experience in generating CDISC ADaM data sets
and TLFs to support clinical study reports, ISS or ISE*.

i.              Create ADaM specifications per CDISC ADaM Implementation
Guide

ii.             Develop and QC ADaM data sets with double programming

iii.            *Create and QC TLFs*

c.             Preparation of electronic submission data package including
define.xml for FDA submissions such as NDA or BLA is a plus.

d.            Statistical background is a plus

III.           Other Requirements. Strong team player and customer focused.
Good written and oral communication skills and interpersonal skills.
Proficiency in Microsoft Word, Excel, and Outlook.

-- 

*Thanks & Regards*

Rathna kumar

Bourntec Solutions, Inc.,

Phone: 847 780 1045

rat...@bourntec.com

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