Vice President, Biometrics

Role Overview

• Lead and oversee all biometrics activities supporting clinical development from IND-enabling studies through regulatory submission.
• Responsible for Biostatistics, Statistical Programming, and Clinical Data Management.
• Serve as the functional head of Biometrics at Janux.
• Work closely with senior leadership to shape clinical strategy, study design, regulatory planning, and data-driven decision-making.
• Provide strategic and operational leadership for the Biometrics function, including Biostatistics, Statistical Programming, and Clinical Data Management.
• Build, lead, and develop a high-performing biometrics organization, including internal staff, consultants, and external partners (e.g., CROs and vendors).
• Lead biometrics strategy and execution across clinical development programs from early development through submission readiness and post-submission support.
• Act as a trusted advisor to senior leadership on statistical methodologies, data strategy, data integrity, and clinical development planning.
• Oversee the design, analysis, and interpretation of clinical trials and preclinical studies, ensuring scientific rigor, regulatory compliance, and high-quality data standards.
• Provide oversight and strategic guidance for statistical analysis plans (SAPs), Tables, Listings, and Figures (TLFs), clinical study reports (CSRs), integrated summaries, and regulatory submission deliverables.

Requirements

• PhD in Biostatistics, Statistics, or a related quantitative discipline required.
• 15+ years of experience in biotechnology or pharmaceutical drug development, including significant leadership experience in biometrics.
• Proven experience leading integrated biometrics functions across Biostatistics, Statistical Programming, and Clinical Data Management.
• Deep experience across all phases of drug development, ideally spanning early-stage development through registration and commercialization support.
• Strong background in oncology therapeutics and drug development; experience in immunology, autoimmune disease, or related therapeutic areas is highly desirable.
• Demonstrated success supporting regulatory submissions and health authority interactions, including NDA/BLA filings and advisory committee preparation.
• Extensive knowledge of clinical trial design, statistical methodology, adaptive designs, and applicable regulatory requirements and guidance (ICH, FDA, EMA, GCP).
• Strong technical expertise, including familiarity with SAS, R, CDISC standards, electronic data capture systems, and modern clinical data platforms.
• Proven ability to build, mentor, and scale high-performing teams in a collaborative and accountable culture.
• Strong executive presence with excellent communication, presentation, and influencing skills
• Demonstrated ability to operate effectively in a fast-paced, hands-on, clinical-stage biotech environment with evolving priorities.
• Strong organizational skills with the ability to manage multiple programs and deadlines simultaneously.
• Commitment to scientific excellence, operational rigor, and continuous process improvement.
• Ability to travel up to 25% as business needs require.

Tech Stack

• Google Cloud Platform

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-paid premiums
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
• Unlimited PTO
• Generous holiday schedule; includes summer and winter company shutdown
• Relocation assistance