Principal Statistician Oncology with Submission Experience

Syneos Health Switzerland GmbH seeks a Principal Statistician Oncology with submission experience for a full-time onsite role in Zürich. The position requires a graduate degree in biostatistics, oncology experience, and proficiency in SAS and R, with responsibilities spanning statistical planning, mentorship, and regulatory support.

This role serves as a key resource within the statistical department, guiding biostatisticians and overseeing training initiatives. The Principal Statistician supports projects from protocol development to clinical study report (CSR) completion, acts as a biostatistics lead on project teams, and contributes to business development efforts by assisting with proposals and sponsor bid meetings.

Responsibilities

• Mentors biostatisticians and develops or oversees training materials for associates.
• Directs biostatistics team members on assigned projects to ensure timely, high-quality deliverables.
• Reviews statistical work produced by other biostatisticians independently.
• Prepares or supervises the creation of Statistical Analysis Plans (SAPs), including mock-ups for tables, listings, and figures.
• Collaborates with sponsors as needed.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS/R annotated CRFs, database designs, and other documentation to ensure alignment with protocol requirements.
• Implements company objectives and develops alternative solutions for business and operational challenges.
• Participates in verification and quality control of deliverables to ensure consistency with SAPs and specifications.
• Manages project schedules, sets goals based on management priorities, and communicates timeline issues to biostatistics leadership.
• Tracks study progress against milestones and ensures project deliverables meet deadlines.
• Provides statistical programming support when required.
• May participate in Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting statistician.
• May serve as a voting statistician on DSMBs or DMCs.
• Reviews and follows applicable SOPs, WIs, and regulatory guidelines (e.g. ICH).
• Maintains organized, complete, and up-to-date project and quality control documentation to ensure inspection readiness.
• Demonstrates teamwork by supporting projects and initiatives as needed.
• Prepares for internal meetings, contributes ideas, and respects others’ perspectives.
• Supports business development by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Performs other assigned duties as required.

Requirements

• Graduate degree in biostatistics or a related field.
• Extensive experience in clinical trials, or equivalent education and experience, demonstrated by ability to lead multiple projects and programs.
• Proficiency in programming.
• Ability to apply deep knowledge of statistical design, analysis, regulatory guidelines, and programming techniques in clinical research, and to communicate statistical concepts effectively.
• Experience across all statistical tasks in clinical trials, from protocol to CSR.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English fluently.
• Oncology experience is required.
• PhD or MS in statistics or related discipline with 6 to 8 years of pharmaceutical industry experience.

Nice to have

• Experience with regulatory submissions is preferred.

What the company offers

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.

About the company

Syneos Health is a leading fully-integrated life sciences services organization focused on accelerating customer success. The company partners with innovators across drug development and commercialization, with a clinical solutions team that applies deep expertise to meet customer needs. It fosters an agile, purpose-driven culture committed to inclusivity and innovation, having supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the past five years.

• Acts with a drug development mindset, leveraging deep expertise to understand customer needs.
• Is agile and driven to deliver for colleagues, customers, and those in need.
• Committed to building an inclusive culture where individuals can be themselves.
• Purpose-driven, with a passion to shape solutions that impact lives.
• Building a company that employees and customers want to work with.
• Brings together smart colleagues globally to shape the future of healthcare.
• Operates in a highly competitive, ever-changing environment that encourages initiative and challenging the status quo.