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AD Biostatistics Late Phase Research (Leadership)

EPM Scientific -
Parsippany-Troy Hills, NJ

Quick Apply

Job Details

Full-time
$160,000 - $190,000 a year
12 days ago

Benefits

Qualifications

Vendor relationship building
Biotechnology
Biostatistics-based research
Pharmaceutical company experience

Full Job Description

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.

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AD Biostatistics Late Phase Research (People Manager)

About the Opportunity

Position Summary

Key Responsibilities

Statistical Leadership & Strategy

Clinical Development & Analysis

Cross-Functional Collaboration

Vendor & Operational Oversight

Scientific & Organizational Influence

Qualifications

Education

Experience