Executive Director of Biostatistics
Confidential, Harrisburg, PA, United States
Executive Director of Biostatistics
About the Company
Late-stage biotech company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking an Executive Director of Biostatistics to take on a senior leadership role within a late-stage biotech environment. The successful candidate will be responsible for overseeing biostatistics and data management across the clinical portfolio, leading the strategy and execution of data management and statistical activities, and managing senior internal leaders. This role also involves providing high-level oversight of external CRO and statistical partners, with a strong focus on clinical development, regulatory readiness, and submission support.
Key responsibilities for the Executive Director of Biostatistics include executive oversight of biostatistics and data management functions, leadership and mentoring of senior data management leadership, and oversight of external CROs, statistical vendors, and consultants. The role requires expertise in statistical planning, analysis, and reporting across clinical trials, as well as the review and approval of key statistical deliverables and outputs. The ideal candidate will have an advanced degree in statistics or a related field, extensive experience in clinical development, and senior-level leadership experience. Strong skills in SAS and CDISC, particularly in SDTM and ADaM, and a deep understanding of regulatory and GCP/ICH requirements are essential. The Executive Director will also be involved in protocol development, study design, and regulatory submissions, and must be prepared to participate in inspections, audits, and health authority interactions.
Travel Percent Less than 10%
Functions
Data Management/Analytics Non-Profit Management
About the Company
Late-stage biotech company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking an Executive Director of Biostatistics to take on a senior leadership role within a late-stage biotech environment. The successful candidate will be responsible for overseeing biostatistics and data management across the clinical portfolio, leading the strategy and execution of data management and statistical activities, and managing senior internal leaders. This role also involves providing high-level oversight of external CRO and statistical partners, with a strong focus on clinical development, regulatory readiness, and submission support.
Key responsibilities for the Executive Director of Biostatistics include executive oversight of biostatistics and data management functions, leadership and mentoring of senior data management leadership, and oversight of external CROs, statistical vendors, and consultants. The role requires expertise in statistical planning, analysis, and reporting across clinical trials, as well as the review and approval of key statistical deliverables and outputs. The ideal candidate will have an advanced degree in statistics or a related field, extensive experience in clinical development, and senior-level leadership experience. Strong skills in SAS and CDISC, particularly in SDTM and ADaM, and a deep understanding of regulatory and GCP/ICH requirements are essential. The Executive Director will also be involved in protocol development, study design, and regulatory submissions, and must be prepared to participate in inspections, audits, and health authority interactions.
Travel Percent Less than 10%
Functions
Data Management/Analytics Non-Profit Management