Offer summary

Qualifications:

PhD or MS in Statistics, Biostatistics, or Mathematics, 3+ years for Sr. Manager; 5+ years for Associate Director in relevant fields, Knowledge of FDA, EU, ICH guidelines preferred, Understanding of drug development.

Key responsabilities:

Provide statistical inputs into clinical studies

Collaborate with internal and external stakeholders

Job description

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 independently or with limited supervision. 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.

Requirements:

PhD or MS in Statistic, Biostatistics, Mathematics, or related field
Sr. Manager: 3+ years (5+ years for MS) of experience in biotechnology, pharmaceutical or health related area
Associate Director: 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area
Knowledge of relevant FDA, EU, ICH guidelines and regulations is preferred
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%)

Salary range for posting

$190,000—$200,000 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.

Required profile