Principal Statistician – Early Phase – Sponsor Dedicated – Program/Project Leader

• Leads the development and execution of a clinical development plan, including defining Go/No Go framework
• Uses simulations and statistical strategy to inform and influence trial design decisions
• Serves as a statistical department resource and mentors biostatisticians
• Oversees or develops training plans and materials and conducts training sessions
• Directs biostatistics personnel on assigned projects and independently reviews project work
• Provides support across statistical tasks throughout the project lifecycle, from protocol to CSR
• Prepares or oversees Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures
• Serves as Lead Biostatistician for protocol statistical aspects, randomization schedules, and clinical study report input
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
• Reviews SAS/R annotated CRFs, database design, and study documentation
• Implements company objectives and develops solutions to business and operational challenges
• Represents biostatistics on project teams and interfaces with other departmental representatives
• Conducts verification and quality control of project deliverables
• Leads complex or multiple projects and supports regulatory agency meetings or responses
• Manages schedules, priorities, timelines, and workload across multiple projects
• Monitors study milestones, deliverables, and out-of-scope tasks
• Provides statistical programming support as needed
• Participates in DSMB/DMC activities, including charter development and statistician roles
• Follows applicable SOPs, WIs, and regulatory guidelines such as ICH
• Maintains complete, up-to-date project and quality-control documentation for inspection readiness
• Supports business development through proposals, budgets, and sponsor bid defense meetings
• Performs other assigned work-related duties

• Master's degree in biostatistics or related discipline
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies
• Program/project level leadership and contributions to clinical development strategy
• Proficiency in R programming
• Extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research
• Ability to effectively communicate statistical concepts
• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR
• Experience with regulatory submissions preferred
• Excellent written and verbal communication skills
• Ability to read, write, speak, and understand English

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Minimal travel may be required