AVP, Biostatistics
- Connecticut
- Permanent
- Full-time
Remote/PermanentThis is a senior leadership position 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.
- Managing 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.
- 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.