About the Role
This role involves leading statistical input across clinical development programs, including study design, analysis plan development, and interpretation of results for regulatory and internal reporting purposes.
Responsibilities
- Lead statistical contributions to clinical trial protocols and statistical analysis plans
- Collaborate with cross-functional teams to ensure data integrity and analytical accuracy
- Develop and execute analysis programs using industry-standard software
- Provide biostatistical expertise during regulatory interactions and audits
- Mentor junior team members in statistical methodologies and best practices
- Ensure compliance with applicable regulatory guidelines and industry standards
- Review case report forms and data collection tools for statistical soundness
- Contribute to the development of data monitoring committee charters and reports
- Support programming validation activities for statistical outputs
- Participate in the interpretation and presentation of clinical trial results
- Oversee the implementation of randomization and blinding procedures
- Guide sample size and power calculation assumptions for study planning
- Assist in the creation of integrated summary of efficacy and safety analyses
- Maintain up-to-date knowledge of statistical methods in clinical research
- Coordinate with external vendors and partners on statistical deliverables
- Ensure timely delivery of high-quality statistical outputs
- Review clinical study reports from a biostatistical perspective
- Support submission-ready documentation for global health authorities
- Apply adaptive design principles where appropriate in trial planning
- Promote the use of innovative statistical techniques in clinical development
- Contribute to process improvement initiatives within the biostatistics group
- Ensure consistency across studies in statistical approach and reporting
- Participate in internal and external scientific meetings
- Manage multiple projects across therapeutic areas
- Ensure adherence to project timelines and quality standards
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model available
Team
Part of a global clinical development team
Therapeutic Areas
Oncology, Central Nervous System, Immunology, Cardiovascular, Infectious Diseases
Work Environment
Fast-paced, collaborative setting with emphasis on innovation and scientific rigor
Career Development
Opportunities for professional growth, training, and leadership roles
Global Impact
Work on clinical trials that support regulatory filings in multiple regions
Technology and Tools
Access to advanced statistical software, cloud computing platforms, and data visualization tools
Collaboration Model
Integrated teams with data managers, programmers, clinicians, and project managers
Performance Expectations
Deliver accurate, timely, and compliant statistical analyses across assigned studies
Compliance and Quality
Adherence to SOPs, regulatory standards, and internal quality benchmarks
Innovation Focus
Encouragement to propose and implement novel statistical approaches
Client Interaction
Regular engagement with sponsor teams and external partners
Available for qualified candidates
