Head of Biometrics

i‑Pharm Consulting; United States; Remote; USD 180,000 - 280,000; Full time

Benefits offered by this job

Remote-first culture

Job summary

i-Pharm Consulting seeks a Head of Biometrics for a biotech client to lead Biostatistics and Statistical Programming. Influence study design, endpoints, and development plans across oncology and rare disease programs.

Drive regulatory submissions and partner with senior leadership to scale the biometrics function. The role combines strategic leadership with hands-on scientific impact in an environment prioritizing AI-enabled analytics and CRO oversight, with a remote-first, long-term growth

Qualifications

• MS or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
• Proven experience leading Biostatistics and/or Biometrics teams within biotech or pharma.
• Experience supporting NDA, BLA, MAA, or equivalent submissions.
• Strong understanding of oncology and/or rare disease clinical development.

Responsibilities

• Lead and grow the Biometrics function across Biostatistics and Statistical Programming.
• Drive statistical strategy across oncology and rare disease programs.
• Influence study design, endpoints, estimands, and development plans.
• Support regulatory interactions and future global submissions.
• Partner with Clinical Development, Regulatory Affairs, and leadership.
• Evaluate opportunities to incorporate AI and automation into biometrics workflows.
• Oversee CRO partnerships and external biometrics vendors.
• Build a scalable function to support pipeline growth.

Skills

Biostatistics leadership

Biometrics leadership

Oncology experience

Rare disease experience

Statistical programming

AI/automation familiarity

Regulatory submissions

Stakeholder management

Education

MS/PhD in Statistics or Biostatistics

Tools

SAS

R

Python

Job description

Oncology & Rare Disease | Clinical Development | AI-Enabled Drug Development

I'm currently supporting an emerging clinical-stage biotech that is entering a significant period of growth.

Backed by a strong investor group and with funding expected to support operations well into the next phase of clinical development, the company has built a robust foundation across Clinical Development, Biometrics, Regulatory Affairs, and Data Science.

With a growing oncology and rare disease pipeline, they're combining a traditional, scientifically rigorous approach to drug development with increased investment in AI, automation, and advanced analytics to enhance decision-making across the organization.

As a result, they're seeking a Head of Biometrics to lead and scale the function through its next stage of growth.

Why This Opportunity?

This is a highly visible leadership role where Biometrics is viewed as a strategic partner rather than a supporting function.

You'll work closely with Executive Leadership, Clinical Development, Regulatory Affairs, Statistical Programming, Data Management, and Data Science to influence development strategy across multiple programs from early development through registration.

The team is currently lean, offering a rare opportunity to shape the future structure, culture, and vision of the Biometrics organization.

What You'll Do

• Lead and grow the Biometrics function across Biostatistics and Statistical Programming
• Drive statistical strategy across a portfolio of oncology and rare disease programs
• Influence study design, endpoint selection, estimands, and development plans
• Support regulatory interactions and future global submissions
• Partner closely with Clinical Development, Regulatory Affairs, and executive leadership
• Evaluate opportunities to incorporate AI and automation into biometrics workflows
• Oversee CRO partnerships and external biometrics vendors
• Build a scalable function capable of supporting continued pipeline growth

Requirements

• MS or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative discipline
• Proven experience leading Biostatistics and/or Biometrics teams within biotech or pharma
• Experience supporting NDA, BLA, MAA, or equivalent submissions
• Strong understanding of oncology and/or rare disease clinical development
• Demonstrated success building, developing, or scaling teams
• Ability to operate strategically whilst remaining close to the science
• Strong communication and stakeholder management skills
• Experience with innovative trial designs, advanced analytics, or AI-enabled processes is highly desirable

Why It's Attractive

• Opportunity to build and scale a Biometrics function
• Strong financial backing and long-term runway
• Growing oncology and rare disease pipeline
• High level of visibility and influence across the organization
• Opportunity to shape the adoption of AI within a traditional clinical development environment
• Blend of strategic leadership and hands-on scientific impact
• Remote-first culture with significant long-term growth potential