The Role:

Reporting to the Senior Director, Biostatistics, this position is responsible for collaboration with internal and external stakeholders to deliver the tactical execution of company’s biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech company.

Key Responsibilities:

• Serve as lead study biostatistician, providing statistical input into study design, sample size, protocol, statistical analysis plans, randomization plans, clinical study reports, and interpretation of statistical analysis results.
• 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.
• Oversee biostatistics and statistical programming vendors to ensure quality, timeliness, and statistical integrity of deliverables.
• Represent Biostatistics on cross-functional study teams and develop effective collaborations with partner lines (such as Statistical Programming, Data Management, Clinical Development, 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.
• Apply innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.

Requirements:

• 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
• Natural collaborator who enjoys working on a cross-functional team in a fast-paced, innovative environment

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (