AD Biostatistics Late Phase Research (People Manager)

Location: New Jersey - 3x a week

Salary:160-190,000 base salary | 20% bonus | RSUs | additional benefits

Client Does not sponsor visas at this time.

About the Opportunity

A growing, innovation-focused biotechnology organization is seeking an experienced Associate Director, Biostatistics to provide strategic and operational leadership across late-stage clinical development programs. This is a highly visible leadership opportunity for a collaborative biostatistics professional who enjoys influencing development strategy, partnering with senior stakeholders, and mentoring teams in a fast-paced environment.

The successful candidate will serve as the lead statistician across one or more clinical programs, drive statistical strategy from study design through regulatory submission, and manage a small team of biostatistics professionals while contributing to the broader growth of the biometrics function. This role includes supervisory responsibility for 1-3 direct reports and offers significant opportunity to shape statistical excellence across the organization.

Position Summary

The Associate Director, Biostatistics will provide scientific leadership and strategic guidance for late-phase clinical studies, including interventional and observational research. This individual will be accountable for the statistical integrity, methodology, analysis, interpretation, and communication of clinical data while serving as a key statistical representative on cross-functional development teams. The role may also serve as a subject matter expert and departmental leader within specific statistical disciplines.

Key Responsibilities

Statistical Leadership & Strategy

• Serve as the lead statistician for one or more clinical development programs.
• Provide strategic input into study design, protocol development, endpoint selection, and evidence-generation planning.
• Partner with Clinical Development and cross-functional stakeholders to define statistical approaches that support program objectives.
• Ensure scientific rigor and regulatory acceptability across all study designs and analytical methodologies.
• Represent Biostatistics in internal governance meetings and external scientific discussions.

Clinical Development & Analysis

• Lead statistical contributions to late-stage clinical trials, observational studies, and post-marketing research initiatives.
• Oversee statistical analyses and interpretation of study data.
• Author and review statistical sections of protocols, Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), publications, and regulatory documents.
• Provide recommendations and insights that inform critical development and business decisions.
• Ensure the delivery of high-quality statistical outputs that meet corporate, regulatory, and departmental standards.

Cross-Functional Collaboration

• Collaborate closely with Clinical Operations, Clinical Development, Data Management, Programming, Medical Affairs, Publications, and external partners.
• Translate complex statistical concepts into clear, actionable insights for technical and non-technical audiences.
• Act as a trusted advisor to project teams and senior leadership on statistical and scientific matters

Team Leadership & People Management

• Directly manage and mentor 1-3 Biostatistics professionals.
• Foster professional growth, technical development, and career progression within the team.
• Promote a culture of collaboration, accountability, quality, and continuous improvement.
• Provide resource planning, workload management, and project prioritization across assigned programs.
• Support talent development initiatives and help build a high-performing biometrics organization.

Vendor & Operational Oversight

• Oversee relationships with CROs, consultants, and external statistical partners.
• Ensure quality, efficiency, and timely delivery of outsourced statistical work.
• Monitor project timelines, resource allocation, and execution across multiple studies.
• Drive process improvements, standardization efforts, and operational excellence initiatives.

Scientific & Organizational Influence

• Maintain awareness of evolving regulatory requirements, statistical methodologies, and industry best practices.
• Champion the application of statistical thinking throughout the organization.
• Serve as a representative for Biostatistics on departmental and enterprise-wide initiatives.
• Contribute to strategic discussions that shape clinical development and evidence-generation approaches.

Qualifications

Education

• PhD or MS in Biostatistics, Statistics, or a related quantitative discipline.

Experience

• Minimum 6+ years of biostatistics experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience serving as a lead statistician on clinical development programs.
• Previous experience managing relationships with CROs, external consultants, or research organizations.
• Prior people leadership experience or demonstrated readiness to manage and develop team members.
• Experience supporting late-phase clinical development and observational studies preferred.