Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices; Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards; Leads/Supports the electronic submission preparation and review; Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
Requirements:
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required; At least 7 years programming experience in industry including support of significant regulatory filings; For US positions: US military experience will be considered towards industry experience; Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
Text:
Manager, Statistical Programming Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices; Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards; Leads/Supports the electronic submission preparation and review; Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required; At least 7 years programming experience in industry including support of significant regulatory filings; For US positions: US military experience will be considered towards industry experience; Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
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