Graduate degree in Statistics or related quantitative field; typically 4+ years industry experience with a PhD or 6+ years with an MS
Strong background in clinical development biostatistics, statistical methods, and industry processes
Proficiency in SAS or R programming
Advanced knowledge of working with CDISC and related FDA standards for the specification and creation of SDTM and ADaM datasets
Demonstrated capability to identify risks, make effective decisions, manage priorities, and deliver results with speed and accountability
Commitment to personal development and supporting team and talent growth; values diverse perspectives and fosters a trusting, collaborative environment
Ability to contribute insights, challenge the status quo, and support innovative, data-driven solutions
Strong ethical judgment and commitment to quality, compliance, and Credo-based decision-making
Excellent communication, collaboration, problem-solving, and interpersonal skills; effective working in cross-functional teams
Leadership/oversight experience in biostatistics operations for clinical development programs
Experience providing statistical support for regulatory submissions and interactions with health authorities
Experience overseeing statistical activities at the project level, including vendor oversight and ensuring compliance with statistical analysis and reporting standards
Experience collaborating cross-functionally and with external partners to support project success, publication strategies, and manuscript development
Experience supporting data interpretation, reporting activities, and publication strategy
Ability to lead and manage biostatistics operations for clinical development programs
