Overview
The Vice President, Biometrics will lead and oversee all biometrics activities supporting clinical development from IND-enabling studies through regulatory submission. This role is responsible for Biostatistics, Statistical Programming, and Clinical Data Management, and will serve as the functional head of Biometrics at Janux.
The VP will work closely with senior leadership to shape clinical strategy, study design, regulatory planning, and data-driven decision-making. This role requires a highly strategic and collaborative leader who can also operate hands-on in a dynamic, fast-paced clinical-stage biotech environment.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- 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.
- Serve as the biometrics functional lead on cross-functional development teams, contributing to study design, statistical strategy, endpoint selection, and key development decisions.
- 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.
- Ensure all biometrics deliverables meet applicable regulatory standards and industry best practices, including CDISC, SDTM, ADaM, and related requirements.
- Support and lead preparation for regulatory interactions and inspections; represent Biometrics in meetings with FDA, EMA, and other global health authorities as appropriate.
- Collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Sciences, Pharmacovigilance, and Quality teams to ensure alignment on study design, execution, and data quality.
- Provide oversight of CRO and vendor deliverables, including database build, CRF design, data review, programming outputs, and TLF production, ensuring quality, timelines, and cost-effectiveness.
- Establish and maintain biometrics systems, standards, processes, and SOPs, including frameworks for CRF development, data collection, database management, and data governance.
- Drive innovation in statistical methodology, adaptive trial design, data analytics, visualization, and technology-enabled processes to support program advancement and decision-making.
- Ensure appropriate resourcing across the biometrics organization, including workforce planning, budget management, and vendor strategy.
- Support business development, diligence, and strategic partnership activities as the biometrics subject matter expert.
- Represent the company externally in scientific, regulatory, and industry forums, as appropriate.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS, AND ABILITIES
- 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.
