Principal Statistician - EMEA (Multiple Locations)

Syneos Health® is a prominent fully-integrated life sciences services organization dedicated to 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.

In this role, you will work alongside passionate problem solvers in either a Functional Service Provider partnership or a Full-Service environment, fostering innovation as a team to help our clients achieve their objectives. We are agile and committed to delivering results for each other, our clients, and, most importantly, those in need.

Responsibilities

• Serve as a statistical department resource, mentoring biostatisticians and overseeing training plans and materials for Biostatistics associates.
• Direct activities of biostatistics personnel on assigned projects to ensure timely, high-quality work, and provide independent reviews of project outputs.
• Support all statistical tasks throughout the project lifecycle, from protocol to Clinical Study Report (CSR).
• Prepare or oversee Statistical Analysis Plans (SAPs) and develop mock-up displays for tables, listings, and figures, collaborating with sponsors as needed.
• Potentially act as Lead Biostatistician for statistical protocol aspects, randomization schedules, and CSR contributions.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS/R annotated case report forms (CRFs), database designs, and study documentation to meet protocol criteria and ensure data quality.
• Implement company objectives and devise alternative solutions for business and operational challenges.
• Interface with project teams as the biostatistics representative, preparing for internal meetings and contributing ideas.
• Conduct verification and quality control of project deliverables, ensuring outputs align with expected results and SAP specifications.
• Manage multiple projects, setting goals based on management priorities, adapting to timeline changes, and proactively communicating challenges.
• Monitor study activities against milestones, ensuring timelines for project deliverables are met and escalating out-of-scope tasks to management.
• Provide statistical programming support as required.
• Participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician.
• Maintain organized and up-to-date project documentation, ensuring inspection readiness.
• Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Perform other related duties as assigned.
• Minimal travel may be required.

Requirements

• Graduate degree in biostatistics or a related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrating the ability to lead multiple projects.
• Proficiency in R programming.
• In-depth knowledge of statistical design, analysis, and relevant regulatory guidelines in clinical research, with effective communication of statistical concepts.
• Experience supporting clinical trials throughout the project lifecycle, from protocol to CSR.
• Preferred experience with regulatory submissions.
• Excellent written and verbal communication skills in English.

About 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 with more than 675,000 trial patients.

At Syneos Health, we are dedicated to developing our people through career progression, supportive management, technical training, and a comprehensive rewards program. We strive to create an inclusive culture where everyone can be their authentic selves, driven by our purpose - Driven to Deliver. Together, we shape solutions that significantly impact lives.

Explore more about Syneos Health at http://www.syneoshealth.com.