Principal Biostatistician – Biomarker Analyst

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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This company has sponsored UK Skilled Worker visas in the past.

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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 and act as the primary sponsor contact for biostatistics activities. • Provide external statistical consultancy and serve as a departmental resource for complex statistical questions, study design, and protocol development. • Plan, execute, and analyze biomarker aspects of clinical and biomarker studies, including genomics and devices. • Develop Biomarker Evaluation Plans and coordinate statistical activities for biomarker research and development. • Design advanced data analyses, statistical programming, and complex analysis algorithms for genomics and biomarker statistics. • Produce and ensure the accuracy of Biomarker Evaluation Reports and statistical deliverables. • Develop standard processes for routine biomarker assessments. • Mentor biostatisticians, oversee training plans and materials, and conduct training sessions. • Direct and independently review biostatistics personnel’s project work. • Support statistical tasks throughout the project lifecycle, from protocol to clinical study report. • Prepare or oversee Statistical Analysis Plans, including mock-up tables, listings, and figures. • Lead statistical aspects of protocols, randomization schedules, and clinical study reports as needed. • Create or review programming specifications, SAS annotated CRFs, database designs, and study documentation. • Conduct verification and quality control of project deliverables. • Lead complex or multiple projects, support regulatory agency meetings, and respond to sponsor questions. • Monitor milestones, timelines, workload, scope, and project deliverables. • Provide statistical programming support and participate in DSMB/DMC activities. • Follow SOPs, work instructions, and relevant regulatory guidelines such as ICH. • Maintain complete, current project documentation and inspection readiness. • Support business development through proposals, budgets, and sponsor bid defense meetings.

🎯 Requirements

• Strong knowledge of biomarker evaluation, particularly in Oncology, ctDNA data, relevant parameters, and underlying biology. • Graduate degree in Biostatistics or a related discipline. • Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies. • Proficiency in R programming. • Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research, and to effectively communicate statistical concepts. • Experience across all statistical tasks required to support clinical trials throughout the lifecycle of the project, 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