Job Details
My client, a clinical stage Biopharmaceutical company working on multiple compounds across a range of therapeutic areas, is looking to bring on a Sr Director of Biostatistics. This person will be heading the Biostatistics function! This person will be responsible for the hands on work at a program/study level in addition to leading/managing a small team of statisticians. The team is looking for someone with strong regulatory submission experience as this role involves close collaboration with key stakeholders to support decision-making, communication, and regulatory submissions.
Key Responsibilities:
- Lead the biostatistics team, overseeing recruitment, development, and retention of top talent.
- Develop and deliver statistical methodology, expertise, and tools to support new medicine development.
- Collaborate with stakeholders to provide timely, high-quality statistical support to clinical programs.
- Ensure integration of advanced statistical expertise into clinical decision-making.
- Supervise project team members, ensuring scientific rigor and cross-functional collaboration.
- Participate in vendor selection, process improvement, and enhancing statistical expertise.
- Ensure compliance with regulatory guidelines and company SOPs.
- Be accountable for statistical activities in regulatory submissions.
- Author relevant sections of regulatory documents and address comments.
- Contribute to abstracts and manuscripts for publications.
- Provide statistical inputs in study-level documents and clinical development programs.
- Develop statistical analysis plans and oversee data management.
- Collaborate on data algorithms, reports, and visualizations for data quality and insights.
- Oversee vendors providing statistical, programming, and data management services.
Qualifications
- PhD in Biostatistics
- 10+ Years of relevant statistical experience in either a Biotech, Pharma or CRO
- Strong People Management Experience
Apply to learn more!