Immunovant · 2 days ago

Associate Director/Director Biostatistics

United States

Full-time

Remote

Director

8+ years exp

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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.

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.

Qualification

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FDA RegulationsDrug DevelopmentStakeholder CollaborationProblem-SolvingCollaborationCommunication