Confidential
Executive Director, Biostatistics Oncology
Confidential, Redwood City, California, United States, 94061
Executive Director, Biostatistics Oncology
About the Company
Esteemed life science company developing innovative medical products
Industry Biotechnology
Type Public Company
Founded 2014
Employees 501-1000
Categories
Health Care Medical Life Science
Business Classifications
B2B
About the Role
The Company is in search of an Executive Director of Biostatistics with a focus on oncology. The successful candidate will be responsible for leading a biostatistics team in the design and execution of statistical strategies, study designs, analyses, and regulatory submissions for late-phase oncology clinical trials. This pivotal role requires a strategic and technical leader who can ensure the team's work is in alignment with clinical development goals and regulatory requirements. The Executive Director will also be instrumental in building and mentoring a high-performing biostatistics team, as well as managing relationships with external partners. A Ph.D. or M.S. in Statistics/Biostatistics, with a minimum of 15 years' (for Ph.D.) or 17 years' (for M.S.) of experience in the biotech/pharma industry, is required, with at least 8 years in a leadership role within late-phase oncology biostatistics.
The ideal candidate will have a proven track record of successful regulatory submissions and direct experience with FDA, EMA, and PMDA interactions. Strong leadership, communication, and project management skills are essential, as is proficiency in SAS and/or R. The role demands a professional with a solid knowledge of ICH and other regulatory requirements related to biostatistical activities and clinical trials, and the ability to influence cross-functional teams and drive strategic initiatives. The Executive Director will be expected to develop and implement policies, standards, and procedures to ensure the quality and consistency of statistical practices, and to lead biostatistical activities for regulatory submissions.
Hiring Manager Title Vice President, Biostatistics
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration Non-Profit Management Operations
About the Company
Esteemed life science company developing innovative medical products
Industry Biotechnology
Type Public Company
Founded 2014
Employees 501-1000
Categories
Health Care Medical Life Science
Business Classifications
B2B
About the Role
The Company is in search of an Executive Director of Biostatistics with a focus on oncology. The successful candidate will be responsible for leading a biostatistics team in the design and execution of statistical strategies, study designs, analyses, and regulatory submissions for late-phase oncology clinical trials. This pivotal role requires a strategic and technical leader who can ensure the team's work is in alignment with clinical development goals and regulatory requirements. The Executive Director will also be instrumental in building and mentoring a high-performing biostatistics team, as well as managing relationships with external partners. A Ph.D. or M.S. in Statistics/Biostatistics, with a minimum of 15 years' (for Ph.D.) or 17 years' (for M.S.) of experience in the biotech/pharma industry, is required, with at least 8 years in a leadership role within late-phase oncology biostatistics.
The ideal candidate will have a proven track record of successful regulatory submissions and direct experience with FDA, EMA, and PMDA interactions. Strong leadership, communication, and project management skills are essential, as is proficiency in SAS and/or R. The role demands a professional with a solid knowledge of ICH and other regulatory requirements related to biostatistical activities and clinical trials, and the ability to influence cross-functional teams and drive strategic initiatives. The Executive Director will be expected to develop and implement policies, standards, and procedures to ensure the quality and consistency of statistical practices, and to lead biostatistical activities for regulatory submissions.
Hiring Manager Title Vice President, Biostatistics
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration Non-Profit Management Operations