Head of Biometrics

Head Of Biometrics

Watertown, Massachusetts, United States

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.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $310,000 - $395,152. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

• Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
• We do not conduct interviews through Skype or Telegram.
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• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.

Notice To Search Firms/Third-Party Recruitment Agencies (Recruiters)

The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.