AVP, Biostatistics
Smith Hanley Associates, Indianapolis, IN, United States
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.
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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.
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