Senior Director, Biostatistics

Key Responsibilities

• Provide oversight and contributions to statistics strategy, planning, execution, and communication for programs as assigned.
• Provide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives.
• Develop effective collaborations with others within clinical teams and partner lines (such as Medical Directors and Regulatory).
• Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.
• Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
• Manage indication/study biostatisticians.

Requirements

• PhD. in Statistic, Biostatistics, Mathematics or related field
• 12+ years of experience in biotechnology, pharmaceutical or health related area
• Knowledge of relevant Health Authority and ICH guidelines, as well as regulations
• Demonstrated experience in engaging with Health Authorities
• Comprehensive understanding of drug development from Phase 2 to launch
• Demonstrated ability to collaborate with diverse sets of stakeholders
• Strong written and oral communication skills with attention to detail
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team

Work Environment

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (

Pay

$270,000 - $310,000 USD

Schedule

Not specified

Benefits

• Full range of medical, dental, vision, 401k
• Unlimited paid time off and parental leave