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Associate Vice President, Biostatistics- Group Head, Immunology
Remote/Permanent

This is a senior leadership position with big pharma and is responsible for guiding statistical strategy and execution within late stage Immunology programs. This role involves providing strategic statistical decision-making, overseeing novel clinical trial designs, and leading a team of statisticians.

Responsibilities:

• Implementing high-quality, scientifically sound statistical strategies for clinical development programs in Immunology.
• Leading a high-performing team of 20+ statisticians.
• Maintaining consistency in statistical methodology, study design, and analysis across various project teams.
• Overseeing the development of statistical analysis plans (SAPs) and contributing to protocol design.
• Ensuring the appropriate statistical methods and data integrity are applied for analysis.
• Effectively communicating complex statistical concepts and findings to non-statisticians.
• Collaborating with cross-functional teams, including physicians, clinical research scientists, regulatory affairs, and data management.
• Representing the statistics department at internal governance meetings, health authority interactions, and scientific conferences.
• Supporting regulatory submissions and responding to queries from health authorities.
• Driving the exploration and application of novel statistical methodologies and tools.
• Staying up-to-date with industry trends and advancements in statistical methodology.

Skills and Experience:

• PhD or Master's degree in Statistics or Biostatistics.
• 15-20+ years of experience in the pharmaceutical/biotech industry required.
• In-depth knowledge of statistical methods, experimental design, and data analysis in clinical development.
• Proven ability to lead and develop high-performing teams.
• Excellent written and oral communication, including presenting complex information to various audiences.
• Demonstrated ability to work effectively with cross-functional teams and senior leadership.
• Understanding of regulatory requirements related to clinical studies and submissions.
• Experience with statistical programming languages such as SAS, R, and Python.