Senior Statistician, Sponsor-dedicated – Early Phase

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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 assigned statistical tasks throughout the project lifecycle, from protocol to clinical study report • Prepare Statistical Analysis Plans, including mock-up tables, listings, and figures • Support statistical aspects of protocols, randomization schedules, publications, and clinical study reports • Coordinate biostatistics and statistical programming personnel to ensure timely, high-quality work • Independently review project work produced by other biostatisticians • Create or review programming specifications for analysis datasets, tables, listings, and figures • Review annotated case report forms, database design, and study documentation • Conduct verification and quality control of project deliverables • Serve as the biostatistics representative on project teams • Manage schedules, priorities, milestones, timelines, and out-of-scope tasks across multiple projects • Provide statistical programming support as needed • Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities • Lead integrated analysis projects and support regulatory agency meetings or responses when needed • Maintain project documentation and quality-control records 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

• Experience and expertise in biostatistics and statistical programming • Ability to prepare Statistical Analysis Plans and mock-up tables, listings, and figures • Knowledge of clinical trial protocols, randomization schedules, publications, and clinical study reports • Ability to create or review programming specifications for analysis datasets, tables, listings, and figures • Experience reviewing SAS-annotated case report forms, database design, and study documentation • Knowledge of verification and quality control processes for project deliverables • Ability to work across multiple projects and manage schedules, milestones, timelines, and changing priorities • Knowledge of applicable SOPs, work instructions, and relevant regulatory guidelines such as ICH • Ability to maintain complete, up-to-date project documentation and inspection readiness • Statistical programming skills • Ability to participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities • Ability to support regulatory agency meetings and responses • 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 • Global career paths and employment opportunities • Minimal travel may be required

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