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