Principal Statistician – EMEA, Sponsor-dedicated

🔥 0 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 10%

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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 activities of biostatistics personnel on assigned projects and independently review project work • Support statistical tasks throughout the clinical trial 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/R 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 • Attend regulatory agency meetings or respond to questions as needed • Manage schedules, priorities, milestones, timelines, and out-of-scope tasks • Provide statistical programming support as needed • Participate in or lead DSMB/DMC activities • Follow applicable SOPs, WIs, and regulatory guidelines • 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 • 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 • Extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research • Ability to effectively communicate statistical concepts • Experience across all statistical tasks required to support clinical trials during 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