Director Biostatistics

Director, Biostatistics Late Stage Oncology (People Manager)

About the Opportunity

We're partnered with a growing, innovation-driven biopharmaceutical organization is seeking a Director, Biostatistics to provide strategic and operational statistical leadership across a portfolio of oncology clinical development programs. This is a highly visible leadership role within the Biometrics organization, partnering closely with Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Statistical Programming, and external partners to drive evidence generation and critical development decisions. The position includes people management responsibilities , leading and mentoring biostatisticians while shaping the overall statistical strategy for the organization.

Position Overview

The Director, Biostatistics will serve as the lead statistical representative for assigned oncology programs, providing scientific guidance across study design, protocol development, analysis planning, regulatory submissions, and interpretation of clinical data. This individual will play a key role in advancing oncology assets through all phases of development and will be expected to influence organizational strategy through strong scientific and leadership capabilities.

Key Responsibilities

Strategic Leadership

• Lead statistical strategy and execution for multiple oncology clinical development programs.
• Serve as the primary Biostatistics representative on cross-functional project teams.
• Provide strategic input into study design, endpoint development, analysis methodology, and evidence generation plans.
• Drive innovative statistical approaches that improve development efficiency and support data-driven decision making.
• Identify and mitigate statistical risks while ensuring quality, compliance, and timely delivery of key project milestones.
• Directly manage, mentor, and develop biostatisticians within the organization.
• Support recruiting, onboarding, performance development, and succession planning efforts.
• Foster a collaborative, high-performance team culture centered on scientific excellence and continuous improvement.
• Provide leadership and oversight to external CRO statisticians and biometrics partners.

Regulatory & Scientific Contributions

• Lead statistical contributions to regulatory submissions, including protocols, Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and integrated summaries.
• Represent Biostatistics in interactions with regulatory agencies and external scientific stakeholders.
• Review and approve key scientific communications, publications, abstracts, posters, and manuscripts.
• Ensure adherence to global regulatory guidelines and industry standards.

Operational Excellence

• Oversee delivery of high-quality statistical analyses and study outputs.
• Ensure effective resource allocation and project prioritization across programs.
• Champion process improvements and best practices within the Biometrics function.
• Partner closely with Statistical Programming, Data Management, Clinical Operations, and Medical teams to deliver integrated development solutions.

Qualifications

Required

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline with 9+ years of pharmaceutical/biotechnology experience
• Extensive Oncology clinical development experience is required , including leadership of oncology studies across multiple phases of development.
• Demonstrated experience serving as the lead statistician for regulatory submissions and health authority interactions.
• Deep expertise in clinical trial design, statistical methodologies, and analysis strategies.
• Strong knowledge of FDA, EMA, ICH, and other applicable regulatory guidelines.
• Proven leadership experience managing and mentoring statisticians.
• Experience overseeing CRO relationships and outsourced biometrics activities.
• Proficiency with SAS and contemporary statistical programming and analysis tools.

Preferred

• Experience supporting late-stage oncology programs and global submissions.
• Exposure to innovative trial designs and complex oncology endpoints.
• Prior success building and scaling high-performing biometrics teams.
• Strong publication and scientific communication record.

What Makes This Opportunity Attractive?

• Visible leadership role with direct influence on oncology development strategy.
• Ability to manage and develop a growing team of biostatistics professionals.
• Opportunity to partner closely with executive leadership and cross-functional stakeholders.
• High-impact position supporting innovative therapies addressing serious unmet medical needs.
• Flexible work model with hybrid Boston or remote options.

Compensation

Base Salary: $230,000 - $270,000, 25% bonus + LTI | additional benefits

Ideal Profile:

A hands-on oncology statistical leader who combines strong scientific depth, regulatory expertise, and proven people-management capabilities to guide both programs and talent in a dynamic biotech environment.