Contract: 1 year
We are supporting an innovative, research-driven biopharmaceutical company in Switzerland that is looking for an experienced Senior Biostatistician to join its Clinical Development team.
In this role, you will take ownership of the statistical strategy and execution for clinical trials, working closely with cross-functional teams to ensure the delivery of high-quality data that drives critical development decisions.
Key Responsibilities
- Lead all biostatistical activities for assigned clinical projects and studies
- Provide statistical expertise and support strategic decision-making within project teams
- Advise stakeholders and management on complex statistical challenges and propose solutions
- Contribute to study design, endpoints, and overall trial objectives
- Develop statistical sections of clinical trial protocols, including methodology and sample size calculations
- Define and oversee randomization strategies
- Author Statistical Analysis Plans (SAPs), including approaches for handling missing data
- Ensure compliance with SOPs, regulatory requirements, and industry standards
- Maintain accurate project timelines and resource estimations
- Oversee and manage outsourced statistical activities performed by external vendors
- Present study results to internal stakeholders and contribute to Clinical Study Reports (CSRs)
- Ensure proper documentation and archival of statistical deliverables at study closure
Requirements
- Degree in Statistics, Mathematics, Biostatistics, or a related quantitative discipline
- Minimum 5 years of experience in clinical statistics within the pharmaceutical, biotechnology, CRO, academic research, or healthcare sectors
- Strong expertise in the application of statistical methods to clinical trials
- Demonstrated experience managing and overseeing external service providers
- Solid understanding of international clinical research regulations and GCP requirements
- Proficiency in SAS; experience with R is highly desirable
- Excellent communication and stakeholder management skills