Asklepios BioPharmaceutical, Inc. (AskBio)

Clinical Operations

• Provide technical leadership and operational oversight for clinical strategies and the design, implementation, and reporting of non-clinical, CMC, and clinical development programs, studies, and trials
• Perform peer review of clinical trial designs and reports for other biostatisticians
• Provide guidance and management to statisticians, programmers, and data managers
• Advise senior leadership and functional leads on biostatistics strategies and business-impacting issues
• Oversee biostatistics functions at CROs and manage scopes of work and external statistical consultant relationships
• Manage resources, set priorities, and ensure consistency with standards
• Collaborate on protocol development, study design, endpoint selection, and power and sample size assessments
• Lead statistical analysis plans, data analysis, and clinical study report content
• Support Data Monitoring Committee charters and meeting preparation
• Represent AskBio in interactions with the FDA, EMA, and other health authorities
• Support regulatory submissions and interactions, including IND and BLA filings, and potential partnering requests
• Provide statistical input to clinical development plans, protocols, investigator brochures, regulatory submissions and responses, publications, and presentations
• Develop and communicate solutions to statistical and data analysis issues
• Contribute to departmental SOPs, standardization efforts, and statistical training
• Maintain current knowledge of statistics, drug development, and regulatory guidance
• Participate in due diligence evaluations, business development activities, scientific and medical meetings, vendor management, and industry conferences

Explore Senior Director, Biostatistics, Clinical Operations at Asklepios BioPharmaceutical, Inc.…. Review requirements and application details.