Director Biostatistics (Santa Clara)

Director Biostatistics - Biotech - ( Onsite)

About our Client : Barrington James is proud to partner with a highly respected, well established biotech client, seeking an experienced Director Biostatistics to join their growing team, this is an excellent opportunity to take in a leadership role in a collaborative, innovative environment working onsite.

Key Responsibilities :

• Lead statistical activities for multiple studies and projects, contributing to trial design, protocol development, and Clinical Study Reports (CSRs).
• Act as a statistical consultant to project teams, offering guidance and input on study methodology and data interpretation.
• Develop and / or review core statistical deliverables including Statistical Analysis Plans (SAPs), integrated summaries of efficacy and safety, interim analysis plans, and TFLs.
• Manage collaborations with CRO statisticians and oversee internal biostatistics resources, including junior statisticians, contractors, and programming staff.
• Represent the biostatistics function in study and project team meetings, providing input on regulatory submissions and participating in regulatory discussions when needed.
• Identify potential statistical challenges, recommend solutions, and engage external experts when appropriate to ensure robust study outcomes.
• Maintain strong communication with functional leadership to align on priorities and ensure high-quality deliverables across programs.

Qualifications & Skills :