Overview

Principal Biostatistician (Rshiny - EMEA & US BASED)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes. Our Clinical Development model centers the customer and the patient, with a focus on simplifying and streamlining work to benefit both clients and employees. This role supports a Functional Service Provider partnership or a Full-Service environment, collaborating with problem solvers to accelerate the delivery of therapies.

We are a global team of 29,000 employees across 110 countries that values a diverse, inclusive culture where everyone belongs.

Responsibilities

• Submit all CVs in English.
• Be located in the following eligible regions: US, UK, Ireland, Poland, Spain, Greece, Hungary, Belgium, Romania, Ukraine, South Africa, Argentina, Mexico, Brazil, or Colombia.
• Set up and maintain an excellent R-based computing environment; add features to apps and fix bugs in existing apps.
• Screen the market for data visualization tools and integrate internal/external apps into the working environment.
• Organize and perform user trainings; provide on-demand user support; stay up to date with the latest technical possibilities.
• Demonstrate expert knowledge in R and R-Shiny, with thorough experience in clinical data structures and programming; apply functional and object-oriented programming.
• Knowledgeable in Javascript/Typescript, HTML, WebGL; experience in CUDA/GPU programming, cloud computing, Github, and web hosting.
• Communicate clearly and work independently or collaboratively; present complex issues effectively.
• Serve as a statistical department resource; mentor biostatisticians; develop training plans and materials; conduct trainings for staff.
• Direct activities of biostatistics personnel on projects; provide independent review of work.
• Provide support across statistical tasks from protocol to CSR; prepare SAPs and mock-up displays; collaborate with sponsor as required.
• May lead as Lead Biostatistician for protocol statistics, randomization, and input to the clinical study report.
• Create or review programming specifications for analysis datasets, tables, listings, and figures; ensure data capture meets criteria.
• Review study documents for protocol criteria and data integrity; support high-quality databases and analyses.
• Implement company objectives and develop alternative solutions to business challenges.
• Collaborate with other department representatives on project teams; contribute ideas and respect others’ opinions.
• Participate in verification and QC of deliverables; ensure alignment with SAP and specifications.
• May lead complex projects and attend regulatory agency meetings; provide statistical input as needed.
• Manage scheduling and time constraints across projects; communicate progress and adjust plans as needed.
• Monitor study milestones; identify out-of-scope tasks and escalate; provide statistical programming support as needed.
• May participate in DSMB/DMC activities and serve as an independent or voting statistician as appropriate.
• Maintain up-to-date project documentation and ensure inspection readiness; comply with SOPs and regulatory guidelines (e.g., ICH).
• Support business development by contributing to proposals, budgets, and sponsor bid defenses.
• Perform other duties as assigned; minimal travel may be required.

Qualifications

• Previous Rshiny experience is required.
• PhD or MS in biostatistics, statistics, mathematics, or data science with a strong computing/informatics emphasis.
• At least two years of experience as a statistician in the Pharma/Biotech or similar sector.
• Excellent R and R-Shiny knowledge; thorough experience in clinical data structures and programming with data; expert in functional and object-oriented programming.
• Knowledgeable in Javascript/Typescript, HTML, WebGL; experience in CUDA/GPU programming, cloud computing, Github, and web hosting.
• Strong communication skills; ability to work independently and collaboratively; ability to present complex issues clearly.
• Team player; fluent in English.

Additional Information

Employment type: Full-time • Seniority: Mid-Senior level

Get to know Syneos Health: We work with a broad range of products and trials globally and are committed to compliance with applicable employment laws and accessibility guidelines.