Confidential
Executive Director, Biostatistics
Confidential, South San Francisco, California, United States, 94080
Executive Director, Biostatistics
About the Company
Innovative biotechnology (BioTech) company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking an Executive Director or Senior Director, Head of Biostatistics to lead the biostatistics efforts for all clinical development programs. The successful candidate will be responsible for providing strong scientific and technical operational oversight across all clinical trials, ensuring rigorous statistical methodology, data integrity, and regulatory compliance. This role requires a collaborative leader with a proven track record in guiding cross-functional teams through early and late-stage clinical trial designs and data analyses, as well as familiarity with global regulatory requirements for statistical data submissions. The Head of Biostatistics will also be involved in managing external vendors and consultants, contributing to regulatory submissions, and leading standardization and process improvement efforts for the biostatistics function.
Candidates for this position must have a PhD in statistics, biostatistics, or a related quantitative field, with a minimum of 10 years' experience in biostatistics supporting clinical trials in the pharmaceutical, biotech, or CRO industry. Essential skills include expertise in designing complex late-stage clinical trials, extensive knowledge of statistical methods for clinical trials, and proficiency in statistical software such as SAS and R. The role also demands experience in global regulatory interactions, cross-functional drug development strategies, and the ability to develop innovative statistical solutions. The ideal candidate will have excellent communication, leadership, and project management skills, and be adept at managing budgets. Familiarity with trial designs for specific therapeutic areas, such as antivirals and liver diseases, is a plus.
Hiring Manager Title EVP, Chief Development Officer
Travel Percent Less than 10%
Functions
Data Management/Analytics Non-Profit Management
About the Company
Innovative biotechnology (BioTech) company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking an Executive Director or Senior Director, Head of Biostatistics to lead the biostatistics efforts for all clinical development programs. The successful candidate will be responsible for providing strong scientific and technical operational oversight across all clinical trials, ensuring rigorous statistical methodology, data integrity, and regulatory compliance. This role requires a collaborative leader with a proven track record in guiding cross-functional teams through early and late-stage clinical trial designs and data analyses, as well as familiarity with global regulatory requirements for statistical data submissions. The Head of Biostatistics will also be involved in managing external vendors and consultants, contributing to regulatory submissions, and leading standardization and process improvement efforts for the biostatistics function.
Candidates for this position must have a PhD in statistics, biostatistics, or a related quantitative field, with a minimum of 10 years' experience in biostatistics supporting clinical trials in the pharmaceutical, biotech, or CRO industry. Essential skills include expertise in designing complex late-stage clinical trials, extensive knowledge of statistical methods for clinical trials, and proficiency in statistical software such as SAS and R. The role also demands experience in global regulatory interactions, cross-functional drug development strategies, and the ability to develop innovative statistical solutions. The ideal candidate will have excellent communication, leadership, and project management skills, and be adept at managing budgets. Familiarity with trial designs for specific therapeutic areas, such as antivirals and liver diseases, is a plus.
Hiring Manager Title EVP, Chief Development Officer
Travel Percent Less than 10%
Functions
Data Management/Analytics Non-Profit Management