Biostatistics Director

Azza HealthCare Agency; Princeton (NJ); On-site; USD 180,000 - 280,000; Full time

Job summary

Azza HealthCare Agency is seeking a Director of Biostatistics to lead statistical activities across early and late-stage programs, serving as a statistical expert and strategic partner for designated compounds. You will shape trial design, analysis plans, and regulatory interactions.

You will mentor teams, oversee SDTM/ADaM/CDISC, ensure ICH-GCP compliance, engage with FDA/EMA, and contribute to regulatory submissions.

Qualifications

• PhD or MS in statistics or related field.
• 12+ years of experience in statistics for drug development.
• Experience with FDA/EMA, SDTM/ADaM/CDISC standards.

Responsibilities

• Lead statistical activities for specific compounds/indications, ensuring consistency across teams.
• Engage with regulatory agencies and represent the team at meetings, providing scientific advice.
• Support integrated data analysis, development of statistical plans, and regulatory documentation.
• Participate in cross-functional teams, review protocols, analysis plans, and reports; collaborate with vendors.
• Ensure SOPs, ICH-GCP compliance; oversee vendor qualification and collaboration.
• Mentor teams, lead statistical methodology development, and contribute to regulatory submissions.

Skills

Statistical analysis

Adaptive trial design

Biostatistics leadership

Regulatory communication

Team mentoring

Education

Master’s or PhD in statistics or related field

Tools

SDTM

ADaM

CDISC

ICH-GCP

Job description

Role Overview

The Director serves as a statistical expert supporting clinical development across early and late-stage programs, acting as a lead for designated compounds or indications. They contribute to strategy, trial design, analysis, and communication with regulatory authorities.

Responsibilities

• Lead statistical activities for specific compounds/indications, ensuring methodological consistency and sharing information across teams.
• Engage with regulatory agencies and represent the team at meetings, providing scientific advice and advancing development strategies.
• Support integrated data analysis, development of statistical plans, and documentation to inform decision-making.
• Participate in cross-functional teams, review trial protocols, analysis plans, reports, and collaborate with vendors.
• Ensure compliance with SOPs, ICH-GCP, and regulatory standards; oversee vendor qualification and collaboration.
• Mentor teams, lead statistical methodology development, and contribute to regulatory submissions.

Qualifications & Skills

• Master’s or PhD in statistics or related field with 12+ years of experience or demonstrated capability.
• Expertise in statistical analysis, modeling, adaptive trial designs, and drug development, especially biologics or targeted therapies.
• Experience with regulatory agencies (FDA, EMA), SDTM, ADaM, and CDISC standards.
• Proven leadership in managing complex projects and mentoring teams.
• Strong communication skills to engage with stakeholders and regulators.

Key Duties

Support clinical trial design, statistical analysis, regulatory interactions, vendor oversight, and contribute to scientific publications, ensuring high-quality, compliant statistical work that advances drug development goals.