A Biostatistics Manager or Director manages a team of statisticians and directs statistical analysis and reporting of health and biology-related data. Analysis may be used for product development at a pharmaceutical company, disease research at a hospital or health policy research at a public health organization. Directs the design of statistical analysis and reviews analysis and findings; may manage regulatory reporting for projects such as clinical trials.
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.
