Barrington James
Director Biostatistics (San Francisco)
Barrington James, San Francisco, California, United States, 94199
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:
PhD in Biostatistics or Statistics ( required) 4 years of pharmaceutical clinical trial experience Strong understanding of SAS and R language
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:
PhD in Biostatistics or Statistics ( required) 4 years of pharmaceutical clinical trial experience Strong understanding of SAS and R language