Clinical SAS Programmer - Katalyst Healthcares & Life Sciences

• 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:

• 5+ years of Statistical Programming experience within the life science industry, preferably on the Sponsor side and relevant BS degree

• Submissions experience, preferably BLA/NDA.

• Experience in Ophthalmology is a plus*.

• Expertise with SAS statistical software.

• R programming is a plus*.

• Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines.

• Experience and understanding of drug development process and clinical trial.