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 – Ophthalmology
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🔥 1 hour 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
• Serve as a statistical department resource and mentor biostatisticians • Develop and deliver training for Biostatistics associates and new hires • Direct biostatistics personnel on assigned projects • Independently review project work produced by other biostatisticians • Support statistical tasks throughout the project lifecycle, from protocol to CSR • Prepare or oversee Statistical Analysis Plans and mock-up tables, listings, and figures • Lead statistical aspects of protocols, randomization schedules, and clinical study reports when assigned • Create or review programming specifications for analysis datasets, tables, listings, and figures • Review annotated CRFs, database design, and study documentation • Represent Biostatistics on project teams and collaborate with departmental representatives and sponsors • Conduct verification and quality control of project deliverables • Lead complex or multiple projects and support regulatory agency meetings or responses • Manage project schedules, milestones, priorities, timelines, and out-of-scope escalations • Provide statistical programming support as needed • Participate in DSMB/DMC activities, including charter development and statistician roles • Follow applicable SOPs, WIs, and regulatory guidelines and maintain inspection-ready documentation • Support business development through proposals, budgets, and sponsor bid defense meetings • Perform other assigned work-related duties
🎯 Requirements
• Graduate degree in biostatistics or a related discipline • Extensive experience in clinical trials or equivalent education and experience demonstrated by ability to lead multiple projects and study programs • Proficiency in R programming • Extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques used in clinical research • Ability to communicate statistical concepts effectively • Experience across statistical tasks supporting clinical trials 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 • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Minimal travel may be required
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