Principal Analyst, Statistical Programming

$130.8k - $179k

Neurocrine Biosciences

San Diego, CA

Responsibilities

Lead design, development, testing, and validation of SAS programs for clinical and non-clinical studies
Provide technical direction for statistical programming standards and infrastructure development
Hire, train, and oversee statistical programmers across Biometrics function
Serve as lead programmer and primary contact for large multidisciplinary projects and agency deliverables
Oversee and validate vendor programming activities including CDISC implementation and e-submission requirements

Requirements

Bachelor's degree in computer science, mathematics, statistics, or related field plus 6+ years biopharmaceutical statistical programming experience
Master's degree in related discipline plus 4+ years similar experience, or PhD plus 2+ years experience
Advanced SAS expertise including Base, Stat, Macro, and graph modules
3+ years supervisory or lead role experience managing statistical programmers
Proficiency with CDISC data structures, SDTM domains, ADaM datasets, and Define.xml files
Expert knowledge of ICH guidelines, 21 CFR Part 11, and FDA submission requirements
Project management skills with ability to lead multiple teams and manage complex vendor relationships

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Vacancy posted a month ago

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