About the Role
This role involves leading statistical activities in early-phase clinical trials, including study design, data analysis, and collaboration with cross-functional teams to support regulatory filings and client deliverables.
Responsibilities
- Design and implement statistical methodologies for Phase I and II clinical trials
- Collaborate with clinical and data management teams to define endpoints and analysis plans
- Develop and review statistical analysis plans and analysis specifications
- Conduct sample size calculations and power assessments for study protocols
- Perform statistical analyses using appropriate software such as SAS or R
- Interpret and present results to internal teams and external clients
- Support regulatory submissions by preparing statistical sections of documents
- Ensure compliance with applicable regulatory guidelines and industry standards
- Mentor junior biostatisticians and provide technical guidance
- Review clinical study reports for statistical accuracy and consistency
- Participate in protocol development and endpoint selection
- Work closely with programming teams to validate analysis outputs
- Contribute to bid defense activities and proposal development
- Maintain up-to-date knowledge of statistical methods and regulatory requirements
- Ensure timely delivery of statistical components within project timelines
Compensation
Competitive salary and performance-based incentives
Work Arrangement
Remote – eligible in EMEA and US locations
Team
Part of a global biostatistics team supporting early-phase drug development programs
Why This Role Matters
You will play a key role in shaping the statistical strategy for innovative early-phase trials, directly influencing drug development decisions and regulatory outcomes.
Growth Opportunities
Access to professional development programs, technical training, and leadership pathways within the biostatistics function.
Client Impact
Deliver high-quality statistical insights that support clients in advancing novel therapies through early clinical development.
Not available for this position
