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Submission Lead Statistical Programmers

Remote:

Full Remote

Work from:

United States

Offer summary

Qualifications:

12-15+ years of SAS Programming experience in life science industry, Experience leading a regulatory submission end-to-end, Familiarity with define.xml, adrg, Pinnacle 21 Enterprise, Knowledge of ICH and FDA/EMEA/ROW guidelines.

Key responsabilities:

Lead submission for assigned compound through SAS programming
Ensure quality and validation of clinical Tables, Listings, and Graphs
Create SDTM and ADaM dataset specifications
Perform end-to-end programming from CRF design to Electronic Submissions
Conduct related programming activities

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

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.