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:
Reporting to the Senior Director, Biostatistics, this position is responsible for collaborating with both internal and external stakeholders to deliver the execution of our Biostatistics strategy. 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 and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, 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.
- Oversight statistics and programming vendors.
- Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
- For Director level:
- Provide oversight and contributions to statistics strategy, planning, execution, and communication for programs as assigned.
- Provide scientifically rigorous statistical input into regulatory submissions and questions and other product support initiatives.
- Identify 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
- Associate Director: 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area
- Director: 8+ years (10+ 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
Work Environment:
- Remote-based; access to Immunovant’s NYC and North Carolina offices available
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel may be required (~10%)