Salary
💰 $190,000 - $210,000 per year
About the role
- 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
- 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%)
Requirements
- PhD or MS in Statistic, 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