AD Biostatistics Late Phase Research (Leadership)
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.
FAQs
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