Principal Statistician - EMEA (Various Locations) Syneos Health® is a leading fully-integrated life sciences services organization focused on accelerating customer success. We collaborate with innovators throughout the drug development and commercialization continuum, helping them navigate complexities and drive progress.

Our Clinical Solutions team operates with a drug development mindset, utilizing extensive experience and expertise to understand customer needs and shape effective solutions. Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll work alongside passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and committed to delivering results for each other, our customers, and, most importantly, those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are dedicated to developing our people through career growth, supportive management, technical training, peer recognition, and a comprehensive rewards program.
• We strive to build an inclusive culture where you can be your authentic self. Our purpose—Driven to Deliver—captures our colleagues' passion to create impactful solutions.
• We continuously work to build a company that our employees want to work for and our customers want to partner with. By bringing together talented individuals from around the world, we can shape the future of healthcare and drive meaningful change.

Job Responsibilities

• Serve as a statistical department resource, mentoring biostatisticians and overseeing or developing training plans and materials for Biostatistics associates.
• Conduct training sessions for new hires and enhance the skills of existing personnel.
• Direct the activities of biostatistics personnel on assigned projects to ensure timely, high-quality work, providing independent review of project outputs.
• Support all statistical tasks throughout the project lifecycle, from protocol development to CSR preparation.
• Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures, collaborating with sponsors as needed.
• May act as Lead Biostatistician, managing statistical aspects of protocols and generating randomization schedules.
• Create or review programming specifications for analysis datasets and ensure compliance with protocol criteria.
• Implement company objectives and develop alternative solutions to business challenges.
• Interface with project team representatives and contribute ideas in internal meetings.
• Conduct quality control of project deliverables to ensure consistency with analyses described in the SAP.
• Manage scheduling and time constraints across multiple projects, adapting to timeline changes and communicating challenges to management.
• Monitor study progress against milestones and ensure timelines are met, escalating out-of-scope tasks as necessary.
• Provide statistical programming support as needed.
• Participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, serving as a non-voting biostatistician or voting statistician as required.
• Maintain organized project documentation and verification/quality control documents, ensuring inspection readiness.
• Support business development by contributing to proposals and attending sponsor meetings.
• Perform other work-related duties as assigned. Minimal travel may be required.

Qualification Requirements

• Graduate degree in biostatistics or a related discipline.
• Extensive experience in clinical trials or equivalent education and experience, demonstrating the ability to lead multiple projects.
• Proficiency in R programming.
• Strong knowledge of statistical design, analysis, regulatory guidelines, and programming techniques in clinical research.
• Experience with all statistical tasks required to support clinical trials, from protocol to CSR.
• Preferred experience with regulatory submissions.
• Excellent written and verbal communication skills, with proficiency in English.

Get to Know Syneos Health

Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter your role, you’ll take initiative and challenge the status quo in a competitive and dynamic environment. Learn more about Syneos Health at http://www.syneoshealth.com.

Additional Information

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks, duties, and responsibilities at its discretion. Equivalent experience, skills, and/or education will also be considered, and the Company will determine what constitutes equivalent qualifications. This document does not create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate to assist employees or applicants in performing essential job functions.