AskBio Inc.

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 to ensure high-quality and timely deliverables
• Advise senior leadership and functional leads on biostatistics strategies and business-impacting issues
• Oversee CRO biostatistics functions and manage scopes of work and external statistical consultant relationships
• Manage resources, set priorities, and ensure adherence to standards
• Collaborate on protocol development, including 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 the Company and Biostatistics function 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 across clinical, regulatory, and commercial teams
• Contribute to departmental SOPs, standardization efforts, and statistical training
• Maintain current knowledge of statistics, drug development, and regulatory guidance
• Participate in due diligence evaluations of external study designs and clinical trial data
• Assist with business development activities at conferences and industry meetings
• Support scientific and medical meetings, including investigator meetings, advisory boards, DMCs, SABs, and interactions with key opinion leaders
• Present at industry conferences representing AskBio
• Participate in vendor evaluation, selection, and management

Explore Senior Director, Biostatistics, Clinical Operations at AskBio Inc.. Review requirements and application details.