Submission Lead Statistical Programmers

Job Description

This a Full Remote job, the offer is available from: United States

Responsibilities:
• Responsible for leading the submission for their assigned compound from the programming side.
• Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs
• Perform validation and QC of the programs, datasets, and statistical reports per study requirements.
• Authors SDTM and ADaM dataset specifications including the identification of potential data issues or areas of critical data examination.
• Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components.
• Other related programming activities.

Requirements:
• 12-15+ years of Statistical SAS Programming experience within the life science industry, preferably on the Sponsor side
• Must have recent experience Leading a regulatory submission end-to-end.
• Experience with define.xml, adrg.
• Must have Pinnacle 21 Enterprise experience.
• Must have worked on a submission within the last year or two.
• Define package experience and ISS/Client experience.
• Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines.

This offer from “Katalyst HealthCares & Life Sciences” has been enriched by Jobgether.com and got a 72% flex score.