Biostatistics Director: Clinical Development Lead

Health Care Administrators Association® (HCAA); Asbury Park (NJ); Sur place; USD 170 000 - 250 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

12+ years in drug development

Regulatory strategy & FDA/EMA

Advanced statistical methods

Leadership and mentoring

Formation

Master’s or PhD in statistics

Experience with SDTM/ADaM/CDISC

Outils

SDTM

ADaM

CDISC standards

Description du poste

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