Sr/Pr Biostatistician - Immunology & Inflammation (Europe and LATAM ONLY)

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 to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We collaborate with passionate problem solvers to help our customers achieve their goals in an agile environment.

This position is open to Europe and LATAM only. Must be eligible to work with no sponsorship needs from the company.

• Study lead for 1-2 protocols (late phase; phase 2-3). For phase 3, may be supporting another main statistic.
• IRT, eCRF, DMC setup, and study risk management planning (SRMP).
• Prepare SAPs, tables, listings, and figures (tfls, STS). Review specifications.
• STS (statistical surveillance) including reviewing blinded data; participate in 2-3 STS meetings during the study life with attention to recruiting the right patients, data looks acceptable, and assessment of statistical assumptions.
• Handling intercurrent events; SAS or R; may partially program the efficacy.
• Provide support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepare SAPs and provide collaboration with the sponsor as required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications, and input to the clinical study report.
• Coordinate activities of biostatistics and statistical programming personnel; provide independent review of project work.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS annotated CRFs, database design, and study documentation to ensure data quality and compliance with protocol criteria.
• Conduct verification and quality control of project deliverables; ensure output aligns with SAP and specifications.
• Implement company objectives and develop alternative solutions to business challenges.
• Serve as biostatistics representative on project teams; prepare for internal meetings and collaborate respectfully with colleagues.
• Manage scheduling and time constraints across multiple projects; communicate timelines and any difficulties to biostatistics management.
• Monitor study progress against milestones and ensure timely deliverables; identify out-of-scope tasks and escalate as needed.
• Provide statistical programming support as needed.
• May participate in Data Safety Monitoring Board / Data Monitoring Committee activities, including charter development and acting as an independent non-voting biostatistician.
• May lead projects involving integrated analyses, attend regulatory agency meetings, or respond to questions to support statistical analysis results.
• Follow applicable SOPs, WIs, and regulatory guidelines (e.g., ICH).
• Maintain organized, complete, and up-to-date project documentation and verification/quality control documents; ensure inspection readiness.
• Support business development by contributing to proposals, budgets, and sponsor bid defense meetings; coach and mentor other Biostatistics staff.
• Performs other duties as assigned. Minimal travel may be required.

Over the past 5 years, we have worked with 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 what your role is, you’ll take the initiative and challenge the status quo in a dynamic environment.