NO REMOTE OR TELECOMMUTE. ALL WORK IS ONSITE.
THIS IS A CONTRACT ROLE: W2 OR CORP TO CORP.
Our Biotechnology client needs to hire a Senior Statistical Programmer for a long term contract based out of their South San Francisco office (position can also reside out of their west Los Angeles location). This company has experienced tremendous success with its oncology drugs in clinical trials and is ready to integrate resources with a clinical SAS programming background into the company.
You must have the ability to gather and analyze user requirements, program complex deliverables, work closely with study team and deliver consistent high quality results on time.
Create SAS programs for data mining
Gather study team requirements and translate them into technical specifications for SAS programs
Program SAS data validation checks and listings to identify data discrepancies
Program SAS checks to integrate and reconcile data from external sources; including serious adverse events (SAE), lab results, ECGs, electronic patient records, medical devices and interactive voice response (IVR)) into the primary clinical database SAS datasets
Review Case Report Forms and formatting of SAS datasets extracts for accuracy and consistency
Provide programming support for Annual Safety Reports and Publications
Build standard SAS Macro library
Skills & Abilities
Excellent SAS 9.2 programming skills
Good organizational skills and ability to prioritize tasks
Must be able to work under tight timelines
Possess excellent communication skills
Bachelors Degree in related area
Knowledge of Oncology clinical trials
Experience with FDA drug submittal is a plus
Minimum of 8+years of SAS programming experience within the biotechnology/pharmaceutical industry
Familiarity with CDISC/ Study Data Tabulation Model (SDTM), ICH/GCP, 21 CFR 11
SAS 9.2 (Datastep, Procedures, Macro, Proc SQL etc)
Familiarity with Data Management software (e.g. Medidata, Oracle Clinical)
Familiarity with coding dictionaries MeDDRA and WHODRUG