Overview
As Principal Statistician at Syneos Health, you will lead biostatistics activities for early-phase projects, mentoring junior statisticians and guiding study design and analysis. You collaborate across sponsor teams to ensure robust SAPs, data handling, and regulatory readiness. You may serve as Lead Biostatistician on protocols and analysis results, and you will help drive timely, high-quality deliverables across complex trials. This role offers influence on study outcomes, interdisciplinary collaboration, and exposure to regulatory interactions within a global, mission-driven CRO.
Verantwortungsbereiche
- Lead and mentor biostatistics personnel across projects
- Develop and review SAPs and analysis plans, including tables, listings, and figures
- Oversee statistical aspects of protocols and randomization schedules
- Review CRFs, data management plans, and databases for quality and completeness
- Provide statistical programming support and ensure QC of deliverables
- Lead or contribute to complex projects such as submissions or integrated analyses
- Participate in DSMB/DMC activities as independent or voting statistician
- Ensure regulatory guideline compliance (ICH, SOPs) and maintain documentation for inspections
- Support business development activities through proposals and sponsor meetings
Zentrale Anforderungen
- Graduate degree in biostatistics or related discipline
- Extensive experience with clinical trials and ability to lead multiple programs
- Proficiency in R programming
- Strong knowledge of statistical design, analysis, and regulatory guidelines
- Experience across lifecycle of trials from protocol to CSR
- Experience with regulatory submissions preferred
- Excellent written and verbal communication skills
- English proficiency (read/write/speak)
- Ability to manage multiple projects and meet timelines
- PhD/MS in statistics or related discipline (stated preference)
- leadership
- effective communication
- collaboration
- R programming
- SAS
- statistical design and analysis
Principal Statistician - Early Phase - Fully home based (remote anywhere in Europe) Sponsor Dedicated Arbeitgeber: Syneos Health
Syneos Health ist ein hervorragender Arbeitgeber, der sich leidenschaftlich für die Entwicklung seiner Mitarbeiter einsetzt und eine inklusive Unternehmenskultur fördert, in der jeder authentisch sein kann. Mit einem starken Fokus auf Karriereentwicklung, technische Schulungen und Anerkennung bietet das Unternehmen zahlreiche Möglichkeiten zur persönlichen und beruflichen Entfaltung. In Nordostdeutschland gelegen, profitieren Mitarbeiter von einem dynamischen Arbeitsumfeld, das Innovation und Zusammenarbeit fördert, um gemeinsam bedeutende Fortschritte im Gesundheitswesen zu erzielen.
