Key Responsibilities:
- Serve as a key member of the Clinical Leadership Team, contributing to the establishment of an effective, well-functioning organization
- Play a leadership role in the design of clinical trials, providing input on study design, trial size, endpoints, etc.
- Provide expert input to enable development plan next steps after key data readouts
- Author biostatistical sections of protocols and statistical analysis plans for studies across indications
- Author statistical section of regulatory submissions; provide input on submissions and regulatory strategy from a biostatistics perspective
- Build and manage internal Biostatistics team and provide oversight of CRO activities
- Establish and ensure compliance with Biostatistics SOPs
Requirements:
- 10+ years of clinical development experience, with an emphasis on statistics, statistical programming, and design and analysis of early and late-phase clinical studies
- Strong SAS programming skills; ability to review programming specifications
- Comprehensive knowledge of statistical analysis and global regulatory requirements relating to clinical development of pharmaceuticals
- Understanding of computer validation
- Able to advise on endpoint selection
- Direct experience with biologics is required; additional experience with small molecules preferred
- Experience with Immunology and Inflammation assets preferred
- Consistently able to produce quick, thorough, and accurate work
- Entrepreneurial spirit; willing to go above and beyond to manage multiple projects simultaneously and achieve key objectives in a fast-paced and fluid environment
- Natural collaborator who enjoys working on a cross-functional team
- Exceptional analytical, interpersonal, and communication skills
- PhD or MS in Statistics or equivalent
- Domestic or international travel may be required (<10%)