Lead biostatistics for multiple development programs: define and execute statistical strategy, contribute to protocols, SAPs, regulatory submissions, ensure compliance, apply innovative methods, collaborate cross-functionally, and manage study biostatisticians.
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:
The Senior Director, Biostatistics will serve as the Biostatistics lead for several Immunovant’s development programs. In this role, you will be collaborating with both internal and external stakeholders to deliver the tactical 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 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 (<10%)
Salary range for posting
$270,000—$310,000 USD
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.
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