Director/Senior Director of Biostatistics

Pathos

104d•Remote

About The Position

The Director/Senior Director of Biostatistics will take ownership of trial-level statistical design, analysis, and regulatory deliverables across our oncology programs. This role reports to the Vice President, Head of Clinical Development, and is ideal for a hands-on biostatistician who thrives on applying rigorous statistical methods to advance clinical development. You will partner closely with clinical, regulatory, and data science colleagues to design and analyze studies, support submissions, and ensure high-quality statistical contributions to key program decisions.

Requirements

PhD or MS in Biostatistics (or related field).
7–12 years of industry experience in biostatistics (oncology preferred).
Hands-on expertise in clinical trial design, statistical analysis, and regulatory deliverables.
Strong SAS/R programming skills.
Demonstrated success with innovative trial methodologies (e.g., adaptive, Bayesian).
Excellent communicator and collaborator across clinical, regulatory, and data teams.
Thrives in a dynamic, fast-paced, environment.

Responsibilities

Lead statistical design and analysis for oncology clinical studies (Phases I–III).
Develop and review statistical sections of protocols, SAPs, study reports, and regulatory documents.
Execute and oversee interim and final analyses, ensuring high scientific rigor.
Apply advanced statistical methodologies (e.g., survival analysis, Bayesian, adaptive designs).
Collaborate with data management and programming teams to ensure data quality and analysis readiness.
Support preparation of regulatory submissions and agency interactions (FDA, EMA, etc.).
Serve as the statistical expert on cross-functional study teams.
Contribute to developing tools, templates, and best practices for the growing biostatistics function.