Associate Director, Biostatistics

Role Summary

Associate Director, Biostatistics at Immunovant, a clinical-stage immunology company focused on autoimmune diseases. The role collaborates with internal and external stakeholders to deliver the execution of the Biostatistics strategy and participates in the rapid growth of a biotech startup.

Responsibilities

• Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, and randomization plans.
• Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers.
• Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory).
• Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.
• Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.
• Oversee statistics and programming vendors.
• Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.

Qualifications

• PhD or MS in Statistics, Biostatistics, Mathematics, or related field
• 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area
• Knowledge of relevant FDA, EU, ICH guidelines and regulations
• Understanding of drug development
• 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

Additional Requirements

• Remote-based; access to Immunovant‚Äôs NYC and North Carolina offices available
• Domestic or international travel may be required (<10%)