Biostatistics Director

Health Care Administrators Association® (HCAA); Asbury Park (NJ); On-site; USD 170,000 - 250,000; Full time

Job summary

Health Care Administrators Association® (HCAA) seeks a Director of Statistics to lead statistical activities for drug development programs, serving as trial lead and expert statistician. You will engage with regulatory authorities, contribute to submissions, and mentor teams while ensuring regulatory compliance and scientific rigor.

The role requires a strong strategic thinker with extensive experience in clinical development and regulatory submission processes, working in a cross-functional

Qualifications

• Master’s or PhD in a statistical discipline.
• 12+ years in drug development and statistical analysis.
• Experience with biologics and regulatory agencies (FDA/EMA).
• Proficiency with SDTM, ADaM, and CDISC standards.
• Leadership of multiple complex projects and mentoring teams.

Responsibilities

• Lead statistical activities for designated compounds/indications with methodological consistency.
• Engage with regulatory authorities and represent the organization at scientific meetings.
• Support integrated database development, analysis planning, and scientific communication.
• Participate in trial design, protocol reviews, vendor oversight, and SPA reviews.
• Mentor teams and ensure compliance with regulatory standards.

Skills

12+ years in drug development

Regulatory strategy & FDA/EMA

Advanced statistical methods

Leadership and mentoring

Education

Master’s or PhD in statistics

Experience with SDTM/ADaM/CDISC

Tools

SDTM

ADaM

CDISC standards

Job description

Role Overview

The Director is a key statistical expert supporting clinical development, serving as compound and/or indication lead for early and late-stage programs, or as trial responsible statistician. They contribute to clinical strategies, ensuring scientific and regulatory compliance, and act as a role model for best practices.

Key Responsibilities

• Lead statistical activities for designated compounds/indications, ensuring methodological consistency and sharing information across trials.
• Engage with regulatory authorities and represent the organization at scientific meetings, contributing to development strategies and submissions.
• Support integrated database development, analysis planning, and scientific communication efforts.
• Participate in trial design, protocol review, vendor oversight, and review of statistical analysis plans, reports, and regulatory documents.
• Collaborate on external vendor qualification, data transfer, and regulatory submission activities.
• Mentor teams, provide expert advice on advanced statistical methodologies, and ensure compliance with industry standards and regulations.

Qualifications & Skills

• Master’s or PhD in a statistical discipline.
• Extensive experience (preferably 12+ years) in drug development, statistical analysis, modeling, and adaptive trial designs.
• Experience with biologics, targeted therapies, and regulatory agencies like FDA, EMA, ICH guidelines.
• Proficiency with SDTM, ADaM, CDISC standards, and regulatory submissions.
• Leadership skills in managing multiple complex projects and mentoring teams.

This role demands a strategic thinker with strong regulatory knowledge, excellent communication, and leadership abilities to drive innovative clinical development efforts.