Clinical SAS Programmer

Responsibilities:

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.