Principal Statistician – Early Phase

🔥 14 minutes ago

🌐 United Kingdom, Armenia, +3 more countries – Remote

🇬🇧 United Kingdom – Remote 🇦🇲 Armenia – Remote 🇩🇰 Denmark – Remote 🇭🇺 Hungary – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🔴 Lead

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Syneos Health

WebsiteLinkedInAll Job Openings

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 oversee training plans and materials; conduct training sessions • Direct biostatistics personnel on assigned projects to ensure timely, high-quality work • 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 SAS/R 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, including submissions and integrated analyses • Support regulatory agency meetings and responses regarding clinical trial statistical analyses • Manage schedules, priorities, milestones, timelines, and out-of-scope task escalation • Provide statistical programming support as needed • Participate in DSMB/DMC activities, including charter development and statistician roles • Follow applicable SOPs, WIs, and regulatory guidelines such as ICH • Maintain complete, current project and quality-control documentation for inspection readiness • Support business development through proposals, budgets, and sponsor bid defense meetings • Perform other assigned duties

🎯 Requirements

• Graduate degree in biostatistics or a related discipline • Extensive experience in clinical trials or equivalent education and experience demonstrated by leading multiple projects and programs of studies • 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 through 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