Principal Analyst, Statistical Programming

• Lead the design, development, testing, maintenance, validation, and documentation of SAS programs evaluating clinical data
• Provide advanced technical statistical programming leadership within Biometrics
• Serve as a technical resource for statistical programmers
• Participate in hiring, training, and oversight of statistical programmers
• Lead large, multidisciplinary projects and serve as the primary Statistical Programming point of contact
• Direct development and implementation of programming standards, conventions, and infrastructure
• Assess workload and projects to ensure programming resources are available
• Oversee and validate vendor programming activities, including CDISC implementation and analysis reporting
• Support creation and validation of e-submission requirements, including annotated CRFs, datasets, and define documents
• Serve as primary or lead programmer for agency reporting deliverables such as DSUR/Annual Report and IB updates
• Perform lead and/or quality control statistical programming on projects as needed
• Perform other duties as assigned

• BS/BA degree in computer science, mathematics, statistics, or related discipline and 6+ years of biopharmaceutical or CRO statistical programming experience; or Master's degree and 4+ years; or PhD and 2+ years
• At least three years of experience serving in a supervisory or lead capacity
• Advanced knowledge of SAS, including Base, Stat, Macro, and graph
• Advanced knowledge of CDISC data structures, SDTM domains, ADaM data sets, and Define.xml files
• Experience managing large projects and external vendors
• Knowledge of best practices in the functional discipline and related business disciplines
• Advanced SAS programming skills and expertise developing and implementing statistical programming SOPs and processes in a clinical environment
• Knowledge of writing, validating, and documenting statistical programs and creating integrated programming libraries and systems
• Project management experience with minimum supervision
• Ability to organize and manage multiple assignments with challenging timelines across multiple personnel
• Advanced understanding of relational databases and complex data systems
• Expert knowledge of ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Advanced programming skills in SAS, R, STAT, or similar
• Proficiency with Word, Excel, and Power Point
• Excellent computer, communication, problem-solving, analytical thinking, project management, and leadership skills
• Ability to work as part of and lead multiple teams
• Ability to meet multiple deadlines with high accuracy and efficiency

Demonstrates advanced expertise in SAS programming, including Base, Stat, Macro, and graph, along with a strong understanding of CDISC data structures and regulatory guidelines. Proven ability to lead multidisciplinary projects, manage teams, and ensure high-quality statistical programming deliverables in a clinical environment.