Senior Director, Head of Biometrics
Confidential, Morristown, NJ, United States
Senior Director, Head of Biometrics
About the Company
Forward-thinking biopharmaceutical company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Senior Director Biostatistics - Head of Biometrics to be its most senior biometrics leader, providing strategic direction and hands-on leadership in biostatistics and statistical programming for clinical development and global regulatory submissions. The successful candidate will be accountable for biometrics strategy, high-quality deliverables, vendor oversight, and inspection readiness, and will work closely with cross-functional leaders to enable data-driven decision-making. Key responsibilities include leading the biometrics function, serving as a trusted advisor to senior leadership, establishing biometrics processes and standards, and owning biometrics budgets and resource planning. The role also involves providing statistical leadership in study design, analysis, and interpretation, and ensuring that biometrics outputs meet regulatory expectations.
Applicants for this role at the company should have an advanced degree in a quantitative field, with a PhD preferred, and at least 12 years of experience in biometrics/biostatistics within a biotech, pharma, or related environment. The ideal candidate will have a proven track record of independent programming in SAS and/or R, deep expertise in clinical trial statistics, and a strong working knowledge of CDISC standards. Experience in managing CROs, vendors, and consultants, as well as supporting regulatory submissions and interactions, is essential. The role requires a strategic thinker with a strong execution mindset, high scientific rigor, and the ability to thrive in a fast-paced, innovative environment. The candidate should also demonstrate strong leadership attributes, including the ability to influence without relying on hierarchy and a collaborative approach to leadership.
Travel Percent Less than 10%
Functions
Data Management/Analytics
About the Company
Forward-thinking biopharmaceutical company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Senior Director Biostatistics - Head of Biometrics to be its most senior biometrics leader, providing strategic direction and hands-on leadership in biostatistics and statistical programming for clinical development and global regulatory submissions. The successful candidate will be accountable for biometrics strategy, high-quality deliverables, vendor oversight, and inspection readiness, and will work closely with cross-functional leaders to enable data-driven decision-making. Key responsibilities include leading the biometrics function, serving as a trusted advisor to senior leadership, establishing biometrics processes and standards, and owning biometrics budgets and resource planning. The role also involves providing statistical leadership in study design, analysis, and interpretation, and ensuring that biometrics outputs meet regulatory expectations.
Applicants for this role at the company should have an advanced degree in a quantitative field, with a PhD preferred, and at least 12 years of experience in biometrics/biostatistics within a biotech, pharma, or related environment. The ideal candidate will have a proven track record of independent programming in SAS and/or R, deep expertise in clinical trial statistics, and a strong working knowledge of CDISC standards. Experience in managing CROs, vendors, and consultants, as well as supporting regulatory submissions and interactions, is essential. The role requires a strategic thinker with a strong execution mindset, high scientific rigor, and the ability to thrive in a fast-paced, innovative environment. The candidate should also demonstrate strong leadership attributes, including the ability to influence without relying on hierarchy and a collaborative approach to leadership.
Travel Percent Less than 10%
Functions
Data Management/Analytics