Job Description
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