Head of Biometrics

Overview

In your role as Head of Biometrics , you will be responsible for leading all biostatistics and statistical programming activities across Treeline’s clinical and translational development programs. This includes ownership of statistical strategy, clinical trial design, statistical analysis planning, and interpretation of results for regulatory submissions, publications, and decision-making. You will build and manage internal and external biometrics capabilities and ensure the delivery of high-quality, timely, and compliant data outputs to support the advancement of the company’s development pipeline. In close collaboration with clinical development, data management, translational sciences, and regulatory affairs, you will play a critical role in ensuring scientifically rigorous and data-driven development strategies.

Key Responsibilities:

• Lead and own the statistical strategy across all stages of clinical development, from study design through regulatory submission.
• Provide statistical leadership for protocol design, randomization, sample size determination, and analysis plans.
• Oversee and review statistical deliverables including SAPs, TFLs, integrated summaries, and ad hoc analyses.
• Collaborate with cross-functional teams to ensure alignment of biometrics strategy with clinical and regulatory goals.
• Serve as the company’s statistical expert in regulatory interactions and ensure compliance with global regulatory standards (FDA, EMA, ICH).
• Lead development of data visualizations, dashboards, analyses, and presentation-ready outputs to support internal decision-making and external presentations for governance meetings, scientific meetings, regulatory interactions, and external partner discussions.
• Manage the statistical programming function and ensure delivery of high-quality datasets and analysis outputs in support of study reports, submissions, and publications.
• Build and lead a high-performing internal biometrics team while managing outsourced CRO partners and statistical consultants.
• Provide leadership in establishing standard operating procedures and data governance best practices for biometrics.
• Help shape the broader data strategy and analytics infrastructure in collaboration with clinical data management, clinical operations, and IT.

Required Qualifications:

• Advanced degree in Biostatistics, Statistics, Mathematics, or a related field
  • PhD + >10 years relevant industry experience
  • MS + >15 years relevant industry experience
• Proven experience leading biostatistics and/or biometrics functions in biotech or pharmaceutical settings.
• Strong knowledge of statistical methodology, clinical trial design, and regulatory requirements.
• Hands-on experience with oncology clinical development strongly preferred.
• Demonstrated success managing external vendors and building biometrics infrastructure in a fast-paced environment.
• Strong communication skills with the ability to translate complex statistical issues to non-technical audiences.
• Foster a collaborative, solutions-oriented biometrics organization focused on responsiveness, quality and support of stakeholder requests – or serve as strategic partner to senior leadership team, delivering timely biometrics insights and presentation support for high-priority and time-sensitive initiatives.
• Strategic thinker with attention to detail, leadership presence, and a commitment to scientific rigor.