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Job Details


Senior Statistical Programmer
North Wales, PA  Posted: 6/20/2019

Details:

Duties & Responsibilities:
This is an advanced level programmer analyst position. Key responsibilities and skills may include, but
are not limited to:
 Programming edit checks for Data Management with SAS;
 Create tables, listings and figures for clinical study report;
 Annotated blank CRF (acrf.pdf) following FDA/CDISC or sponsor guidelines;
 Create or QC SDTM specifications and SDTM datasets;
 Create or QC simple ADaM specifications;
 Create or QC ADaM datasets;
 Create define.xml or define.pdf following FDA/CDISC or sponsor guidelines with minimum
supervision;
 Serve as a mentor for junior team members;
 Serve as a working group lead for department initiatives
Essential Skills Required & Education:
The candidates should ideally possess the following qualifications:
 BS/MS in statistics or related science with 3+ years of experience in the pharmaceutical industry,
respectively.
 Hands-on skills in legacy data conversions to CDISC SDTM data sets, good working experience
in generating CDISC ADaM data sets and TLFs to support clinical study reports,
 ISS or ISE. Preparation of electronic submission data package including define.xml for FDA
submissions such as NDA or BLA is a plus.
 Strong team player and customer focused.
 Good written and oral communication skills and interpersonal skills.
 Proficiency in Microsoft Word, Excel, and Outlook.

Job ID#:

6476

 



 

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