Senior Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and contribute to the statistical strategy, planning, execution, and communication for assigned programs.

• Provide scientifically rigorous statistical insights into clinical development plans, protocol creation, statistical analysis strategies, regulatory submissions and inquiries, interpretation of statistical analysis results, and other product support activities.

• Foster effective collaborations with members of clinical teams and partner divisions (including Medical Directors and Regulatory).

• Ensure all statistical activities at the study and project levels adhere to applicable regulatory standards and Immunovant guidelines.

• Identify opportunities to apply innovative statistical methodologies to enhance the clinical development process and support optimal decision-making.

• Oversee indication/study biostatisticians.

⛳️ Requirements

• PhD in Statistics, Biostatistics, Mathematics, or a related discipline.

• Over 12 years of experience in the biotechnology, pharmaceutical, or health-related sectors.

• Familiarity with relevant Health Authority and ICH guidelines, as well as regulatory frameworks.

• Proven experience in engaging with Health Authorities.

• Extensive understanding of drug development processes from Phase 2 through to launch.

• Demonstrated ability to collaborate effectively with a diverse range of stakeholders.

• Excellent written and verbal communication skills, with a keen eye for detail.

• Passion for working in a dynamic, innovative environment.

• A natural collaborator who thrives in cross-functional team settings.

🏝️ Benefits

• Comprehensive medical, dental, and vision coverage.

• 401k retirement plan.

• Unlimited paid time off.

• Parental leave.