Sr/Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA)

Syneos Health Switzerland GmbH seeks a Senior/Principal Statistician for a sponsor-dedicated role in Zürich, CH. The position involves supporting clinical trial projects from protocol to clinical study report, with responsibilities in statistical planning, programming, quality control, and team coordination. Hybrid work model, full-time, with minimal travel required.

This role supports the full lifecycle of clinical trial projects, from protocol development to clinical study report, serving as the biostatistics lead on project teams and contributing to business development efforts such as proposal development and sponsor bid defense meetings.

Responsibilities

• Develop Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures, and collaborate with sponsors as needed.
• Handle statistical components of protocols, randomization schedules, publications, and input to clinical study reports.
• Coordinate biostatistics and statistical programming staff on assigned projects, ensuring timely, high-quality delivery, and independently review work from other biostatisticians.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS annotated CRFs, database designs, and study documentation to ensure protocol compliance and data capture adequacy.
• Participate in verification and quality control of deliverables, ensuring alignment with SAPs and specifications.
• Implement company objectives and develop alternative solutions for business and operational challenges.
• Manage project schedules and time constraints, adjust priorities as needed, and communicate timeline issues to biostatistics management.
• Track study progress against milestones and escalate out-of-scope tasks to management.
• Provide statistical programming support as required.
• Participate in Data Safety Monitoring Board or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
• Lead integrated analyses, attend regulatory meetings, or respond to agency queries to support trial results on behalf of the sponsor.
• Adhere to SOPs, WIs, and regulatory guidelines such as ICH.
• Maintain organized, complete, and up-to-date project and quality control documentation to ensure inspection readiness.
• Collaborate with colleagues and support business initiatives as needed.
• Mentor and coach other biostatistics team members.
• Perform other assigned duties.
• Minimal travel may be required.

Requirements

• PhD or MS in statistics or a related field, with at least 3 years of experience in the pharmaceutical industry.
• Strong understanding of advanced statistical concepts and methods.
• Ability to perform advanced statistical analyses using SAS or R.

Nice to have

• Experience with meta-analyses and late-phase clinical trials is strongly preferred.