CDx Biostatistics Leader

Title: Associate Director / Director / Senior Director, Biostatistics (CDx)

Location: Boston

We are seeking a highly experienced and strategic CDx Biostatistics Leader to drive biostatistical strategy and execution across companion diagnostic (CDx) development programs, with a strong focus in Oncology. This role is pivotal in ensuring the statistical integrity and regulatory readiness of diagnostic assets, particularly those involving tissue-based protein assays such as immunohistochemistry (IHC) and immunofluorescence (IF).

Key Responsibilities:

• Lead biostatistical planning and analysis for CDx development programs, from early feasibility through regulatory submission.
• Collaborate cross-functionally with clinical development, regulatory affairs, translational science, and diagnostic partners to ensure alignment on statistical methodologies and CDx strategy.
• Design and analyze studies supporting CDx validation, including analytical performance, clinical utility, and regulatory compliance.
• Provide statistical oversight for assay development and validation, particularly for IHC and IF-based platforms.
• Author and review statistical sections of regulatory submissions (e.g., IDE, PMA, BLA) and interact with health authorities as needed.
• Mentor and guide junior biostatisticians and contribute to the development of best practices in CDx biostatistics.

Experience:

• Education: PhD in Biostatistics, Statistics, Mathematics
• 6+ Years of Industry Experience (Diagnostic Development Experience)
• Hands-on experience with tissue-based protein assays, especially IHC and/or IF.
• Proven track record of successful regulatory submissions involving CDx.
• Proficiency in statistical software (e.g., SAS, R)
• Strong Oncology Background