Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
Principal Statistician – Early Phase – Sponsor Dedicated – Program/Project Leader
🔥 20 minutes ago
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Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
📋 Description
• 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
🎯 Requirements
• 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
🏖️ Benefits
• 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
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