Principal Biostatistician – Integrated Analysis Experience Required

🔥 0 minutes ago

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

🇬🇧 United Kingdom – Remote 🇧🇪 Belgium – Remote 🇬🇷 Greece – Remote 🇳🇱 Netherlands – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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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

• Lead projects across multiple studies or programs • Act as primary sponsor contact for biostatistics activities • Provide statistical consultancy and serve as a resource for complex statistical questions, study design, and protocol development • Mentor biostatisticians and oversee or develop training plans and materials • Direct biostatistics personnel and independently review project work • 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 as needed • Create or review programming specifications for analysis datasets, tables, listings, and figures • Review SAS-annotated CRFs, database design, and study documentation • Interface with cross-functional project team representatives • Conduct verification and quality control of project deliverables • Lead complex or multiple projects, including submissions and integrated analyses • Support regulatory agency meetings and responses to regulatory questions • Manage schedules, priorities, milestones, timelines, and out-of-scope tasks • Provide statistical programming support as needed • Participate in DSMB/DMC activities, including charter development and statistician service • 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 work-related duties

🎯 Requirements

• Graduate degree in biostatistics or related discipline – Master Degree (minimum) • Hands-on integrated analysis experience with IASAP and TLF specifications, additional derivations, draft table reviews, and planning/coordinating analyses to support labeling • Deep understanding of clinical development plans and submission strategy, with experience contributing to submission planning and Benefit/Risk analyses • Ability to independently manage regulatory authority requests and partner with clinical teams • Extensive experience in clinical trials or an equivalent combination of education and experience • Proficiency in programming • Extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research • Experience across all 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 • Minimal travel may be required