FierceBiotech and FiercePharma Jobs
Senior Clinical SAS Programmer Analyst - Verna Scientific
Dec 20
Location: Hayward, CACategories: Pharmaceutical
Website: http://www.vernascientific.com
Position Description
Urgent requirement for one of our top clients located in “Hayward, CA”.
Please contact me at your earliest convenience, along with job No. SCSP_122008 to glenn.davis@vernascientific.com
Description:
Support Biostatisticians, writers and clinical staff in statistical analysis, including generating data summaries, listings, tables, figures and ad-hoc reporting. Support Data Management in database creation, transfers, integrity checks, and audits. Validation of programming code used to produce tables and data for submissions to regulatory agencies. Ensure completeness, correctness and consistency of clinical data and data structure. Work closely with statisticians on dataset specifications and programming details. Review clinical study protocols and CRFs.
Requirements:
Bachelor's degree required, advanced degree preferred. A minimum of 7 years of experience as a statistical programmer using SAS in a pharmaceutical or CRO environment. A minimum of 7 years of SAS programming for ISS/ISE and NDA submissions. Experience with ISS/ISE and NDA submissions in paper 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.
