Senior SAS Programmer - South Bay (Sunnyvale)

•Assist in specific CDISC data standards for reports and regulatory submissions
•Will support Data Management in database creation, transfers, integrity checks, and audits.
•Will validate code used to produce TLGs and data submissions to regulatory agencies.
•Assist in QA (i.e. completeness, correctness and consistency of clinical data and data structure)
•Support Biostatisticians and Medical Writers with statistical analysis, including generation of data summaries, tables, listings, figures and ad-hoc reporting
•Review clinical study protocols and CRFs

Mandatory Requirements:

•A minimum of 4 years of experience as a SAS programmer (in Pharma and/or CRO)
•Some work experience in SAS programming for ISS/ISE and NDA submissions.
•Experienced with paper submission and electronic or eCTD form.
•Significant knowledge and hands-on experience in CDISC/SDTM standards.
•Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
•Advanced skills in SAS programming language, especially data null, data step programming and report writing.
•Knowledge of advanced statistical procedures in SAS, e.g., LIFETEST, MIXED, GLM.

Experience: 4+ is the minimum years of experience to be considered for this role