About the job
We are currently working with a small, Neurology focused commercial Biotech that are looking for an Director / Associate Director of Biostatistics to be one of the first statisticians in the biometric unit and play a key role in growing and shaping the statistics team across the U.S.
Our client has successfully launched four products to market and have a very robust pipeline. As result of this they are looking to grow significantly over the next 18 months across various departments in the business.
This is a full time on-site position with a requirement to work from the offices in Washington DC. A very competitive remuneration package can be offered, as well as relocation support.
Responsibilities:
- Serve as the lead statistician for several studies and programs spanning multiple therapeutic areas, contributing to trial design, protocol drafting, and the preparation of Clinical Study Reports (CSRs).
- Engage in study-level activities by offering statistical guidance, consultation, and support to cross-functional partners throughout the project lifecycle.
- Create and/or evaluate key statistical deliverables—such as Statistical Analysis Plans (SAPs), integrated efficacy and safety summaries, tables/figures/listings (TFLs), and interim analysis plans—to ensure high-quality outputs for clinical trials.
- Oversee the work of CRO statisticians and internal biostatistics staff, including junior and contract statisticians as well as programming teams, to facilitate smooth biostatistical operations.
- Act as the biostatistics representative on project and study teams, attending relevant meetings and contributing to activities tied to regulatory submissions, inquiries, and discussions. Maintain ongoing communication with the functional manager.
- Provide statistical leadership by identifying risks or methodological challenges, suggesting solutions, and involving external subject-matter experts when specialized input is required.
Requirements:
- PhD in Biostatistics or Statistics
- Extensive experience working in clinical trials
- Proficient skills with SAS
- In-dept knowledge of clinical trials methodology and regulatory requirements
- Extensive experience working within a CRO or Pharma/Biotech sponsor environment
Featured benefits
- Medical insurance
- Dental insurance
- 401(k)
- Vision insurance
For more information on this position, please submit your application, or reach out to Jack Kavanagh.
Jack Kavanagh
AL Solutions