VP, Biometrics: Clinical Data Strategy & Submissions

Elicio Therapeutics; Boston (MA); On-site; USD 310,000 - 448,000; Full time

Job summary

Elicio Therapeutics is seeking a VP, Biometrics (Consultant) to lead biostatistics and programming across clinical development. You will shape statistical strategy, ensure data quality, and drive submission readiness while engaging global regulators and partners.

You will manage CROs, mentor teams, and contribute to publication plans. Oncology experience and NDA/BLA familiarity are essential for this senior role.

Qualifications

• MS or PhD in statistics, biostatistics or related field with 15+ years in Pharma/Biotech.
• Extensive clinical trial experience including time-to-event data and 10+ years in leadership.
• Strong leadership, communication and cross-functional collaboration skills.
• Experience in oncology and with small pharma/biotech environments.
• Familiar with ICH, FDA/EMA regulatory expectations and NDA/BLA submissions.

Responsibilities

• Oversee biostatistics and statistical programming for clinical development and regulatory filings.
• Provide strategic leadership to study design, analysis plans and endpoints.
• Lead CROs for outsourced biometrics activities to ensure cost, timing and quality.
• Advise on publication strategy and presentations; engage with regulators as needed.
• Shape integrated global development plans with Clinical Development and Regulatory Affairs.

Skills

Biostatistics leadership

Statistical programming

Regulatory submissions

CRO/vendor management

Cross-functional collaboration

Clear communication

Education

MS or PhD in statistics/biostatistics

Tools

eCTD submissions

Job description

Elicio Therapeutics is seeking a VP, Biometrics (Consultant) to lead biostatistics and programming across clinical development. You will shape statistical strategy, ensure data quality, and drive submission readiness while engaging global regulators and partners.

You will manage CROs, mentor teams, and contribute to publication plans. Oncology experience and NDA/BLA familiarity are essential for this senior role.