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.
Senior Statistician – Sponsor-dedicated, Early Phase
🔥 1 minute 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
• Provide support across all assigned statistical tasks during the project lifecycle, from protocol to CSR • Prepare Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures • Collaborate with the sponsor as required • Support statistical aspects of protocols, randomization schedules, publications, and clinical study reports • Coordinate biostatistics and statistical programming personnel on assigned projects • Independently review project work produced by other biostatisticians • Create or review programming specifications for analysis datasets, tables, listings, and figures • Review SAS-annotated CRFs, database design, and study documentation • Conduct verification and quality control of project deliverables • Serve as the biostatistics representative on project teams • Manage scheduling and timelines across multiple projects • Monitor study activities against milestones and escalate out-of-scope tasks • Provide statistical programming support as needed • Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities • Lead integrated analyses and support regulatory agency meetings or responses as needed • Follow SOPs, work instructions, ICH guidelines, and relevant regulatory requirements • Maintain complete, current project and quality-control documentation for inspection readiness • Support business development through proposals, budgets, and sponsor bid defense meetings • Coach and mentor Biostatistics staff • Perform other assigned work-related duties
🎯 Requirements
• Equivalent experience, skills, and/or education will be considered • Ability to perform assigned statistical tasks across the clinical-trial project lifecycle • Ability to prepare Statistical Analysis Plans and mock-up tables, listings, and figures • Ability to support protocol statistics, randomization schedules, publications, and clinical study reports • Ability to coordinate and independently review biostatistical work • Experience creating or reviewing programming specifications for analysis datasets, tables, listings, and figures • Knowledge of SAS-annotated case report forms, database design, and study documentation • Ability to perform verification and quality control of project deliverables • Knowledge of applicable SOPs, work instructions, ICH guidelines, and relevant regulatory guidelines • Ability to manage multiple project schedules, milestones, priorities, and timelines • Ability to provide statistical programming support • Ability to participate in Data Safety Monitoring Board/Data Monitoring Committee activities • Ability to support regulatory agency meetings and responses • Ability to contribute to proposals, budgets, and sponsor bid defense meetings • Ability to coach and mentor Biostatistics staff • Minimal travel may be required
🏖️ Benefits
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Career paths and employment opportunities • Global team collaboration • Minimal travel may be required
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