Director Biostatistics

Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

(Associate) Director, Biostatistics leads clinical studies and supports clinical study protocols for statistical as well as broader drug development concepts. This role performs or oversees the analysis of clinical trial data, provides statistical interpretation of results, and collaborates on the reporting of clinical trial results to cross functional teams. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.

Key Responsibilities:

• Provide statistical inputs into protocol development, author statistical analysis plans, provide interpretation of statistical analysis results, review randomization plans
• Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, and specifications of variable derivations
• Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory, etc)
• 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
• Oversight statistics and programming vendors
• Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making

Requirements:

• PhD or MS in Statistic, Biostatistics, Mathematics, or related field
• For Associate Director: 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area
• For Director: 7+ years (9+ 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 details
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team

Work Environment:

• Remote-based; Immunovant’s headquarters is in NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel may be required (<10%)

Tags