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Posted on : 21 March 2017
To perform this job successfully an individual must be able to perform each essential function satisfactorily. " Generate randomization schedules. " Provide sample size calculations. " Provide input into development of case report forms (CRFs). " Author statistical analysis plans, including development of table and listing shells. " Review statistical analysis plans written by CRO Biostatisticians. " Generate/Validate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS. " Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. " Perform quality control for SAS programs and other study documents (e.g., presentations and reports). " Provide statistical analysis and reports to Data Monitoring Committees (DMCs). " Review output across programs to ensure consistency. " Prepare statistical sections of clinical study reports. " Other duties as assigned. QUALIFICATIONS: " Master s degree in Statistics and a minimum of 5 years of relevant industry experience. " Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines. " Experience with SAS. " Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines. " Excellent communication and interpersonal skills to effectively interface with others. REQUIRED KNOWLEDGE AND ABILITIES: " Strong verbal and written communication skills are essential. " Excellent organization and multi-tasking skills. " Exceptional interpersonal skills and problem solving capabilities. " Proven meeting planning skills. " Ability to work effectively across a matrix organization. " Ability to work independently and prioritize with minimal daily instruction. " Ability to think strategically in order to improve current processes.
San Diego CA United States
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