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| | From: 787birth (Original Message) | Sent: 3/25/2006 2:48 AM |
Loc : Indianapolis,IN Employment : Permanent placement Salary : $60-65k(pa) US CITIZENS or GREEN CARD HOLDER ONLY START ASAP Clinical Statistical Programmer POSITION SUMMARY: Provides programming support, including documentation and validation, for producing integrated analyses, databases, listings, summaries, figures, and tables for Phase 3-4 clinical studies, along with integrated safety analyses, integrated efficacy analyses and publication requests. PRINCIPAL ACCOUNTABILITIES: o Review reporting requirements in consultation with Clinical Statisticians and Medical Writers o Statistical reporting, creation of Tables Figures and Listings using SAS programming o Validation of output results using Statistics Standard Operating Procedures o Create Case Study Reports (CSR’s) using integrated databases for submission to FDA o Create SAS reusable components to automate reporting o Provide SAS Training to junior team members o Identifies opportunities for process improvement and code optimization EXPERIENCE: Masters in Statistics or Engineering degree with 3-5 years of pharmaceutical experience in clinical programming and submission preparation. At least 3 years experience with SAS software system and good understanding of health authority regulations and guidelines regarding programming and computer system validation. SKILLS: o Clinical Data Analysis o Clinical Data Management o Documentation Skills o Excellent Communication Skills S/W SKILLS: Base SAS, SAS STAT, SAS GRAPH, SQL. ESSENTIAL SKILLS: o SAS o Clinical Data Analysis o Excellent communication skills |
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