Principal Statistician, Early Phase - Remote Europe Lead

Syneos Health, Inc.; Noord-Holland; Remote; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Syneos Health, Inc. is seeking a Principal Statistician for Early Phase, fully home-based across Europe. The role leads clinical development planning, applies simulations for design decisions, mentors statisticians, and oversees multi-project activities.

You will drive SAP development, data reviews, and regulatory interactions, with broad posting and collaboration across teams. PhD/MD or equivalent is desirable with extensive biostatistics experience in early-phase trials, strong leadership, and

Qualifikationen

• Master's degree in biostatistics or related discipline.
• Proficiency in R programming.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.
• Experience across all statistical tasks for clinical trials.

Aufgaben

• Leads the development and execution of a clinical development plan, including defining Go/No Go framework.
• Uses simulations and statistical strategy to inform and influence trial design decisions.
• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of SAPs, including development of mock-up displays for tables, listings, and figures.
• May be responsible as Lead Biostatistician for protocol, randomization, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS/R annotated CRFs, database design, and other study documentation to support data capture.
• Implements company objectives and creates alternative solutions to address business challenges.
• As biostatistics representative on project teams, interfaces with other departmental project team representatives.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts and participates in verification and quality control of project deliverables.
• May lead complex or multiple projects and attend regulatory agency meetings to support analyses.
• Manages scheduling across multiple projects and communicates timelines to management.
• Monitors progress on study activities against milestones.
• Provides statistical programming support as needed.
• May participate in DSMB/DMC activities and follow regulatory guidelines.
• Maintains organized project documentation and inspection readiness.
• Supports business development activities by contributing to proposals and budgets.
• Performs other duties as assigned. Minimal travel may be required.

Kenntnisse

Leadership

Communication skills

Project management

Biostatistics knowledge

English proficiency

Ausbildung

Master's degree in biostatistics or related discipline

Tools

R programming

SAS programming

Jobbeschreibung

Syneos Health, Inc. is seeking a Principal Statistician for Early Phase, fully home-based across Europe. The role leads clinical development planning, applies simulations for design decisions, mentors statisticians, and oversees multi-project activities.

You will drive SAP development, data reviews, and regulatory interactions, with broad posting and collaboration across teams. PhD/MD or equivalent is desirable with extensive biostatistics experience in early-phase trials, strong leadership, and