Vice President, Biometrics
Janux Therapeutics
August 23, 2026
Remote friendly (San Diego County, CA)
United States
Clinical Research and Development
Essential Functions and Responsibilities:
- Provide strategic and operational leadership for Biometrics, including Biostatistics, Statistical Programming, and Clinical Data Management.
- Build, lead, and develop a high-performing biometrics organization (internal staff, consultants, and external partners such as CROs and vendors).
- Lead biometrics strategy and execution across clinical development programs from early development through submission readiness and post-submission support.
- Serve as biometrics functional lead on cross-functional teams to shape study design, statistical strategy, endpoint selection, and key decisions.
- Advise senior leadership on statistical methodologies, data strategy, data integrity, and clinical development planning.
- Oversee design, analysis, and interpretation of clinical trials and preclinical studies with scientific rigor, regulatory compliance, and high-quality data.
- Oversee SAPs, TLFs, CSRs, integrated summaries, and regulatory submission deliverables.
- Ensure deliverables meet regulatory and industry best practices (CDISC, SDTM, ADaM).
- Support regulatory interactions/inspections; represent Biometrics with FDA, EMA, and other authorities as appropriate.
- Oversee CRO/vendor deliverables (database build, CRF design, data review, programming outputs, TLF production).
- Establish biometrics systems, standards, processes, and SOPs; drive innovation in statistical methods and technology-enabled processes.
Education and Qualifications:
- PhD in Biostatistics, Statistics, or related quantitative discipline (required).
- 15+ years in biotech/pharma drug development with significant biometrics leadership.
- Experience leading integrated biometrics across Biostatistics, Statistical Programming, and Clinical Data Management.
- Deep knowledge across drug development phases, ideally early-stage through registration/commercialization support.
- Strong oncology background; immunology/autoimmune experience highly desirable.
- Experience with regulatory submissions (e.g., NDA/BLA) and health authority interactions.
- Strong expertise in adaptive design/statistical methodology and ICH/FDA/EMA/GCP requirements.
- Technical skills: SAS, R, CDISC, EDC systems, modern clinical data platforms.
- Proven ability to build/mentor/scale teams; executive communication and influencing skills.
- Ability to operate hands-on in a fast-paced environment; strong organization and ability to manage multiple programs.
- Travel up to 25%.
Benefits:
- Annual bonus program; incentive stock option plan; 401k plan; comprehensive medical (90–100% employer-paid premiums); dental/vision; HSA/FSA; supplemental insurance; unlimited PTO; generous holiday schedule; relocation assistance.
- Provide strategic and operational leadership for Biometrics, including Biostatistics, Statistical Programming, and Clinical Data Management.
- Build, lead, and develop a high-performing biometrics organization (internal staff, consultants, and external partners such as CROs and vendors).
- Lead biometrics strategy and execution across clinical development programs from early development through submission readiness and post-submission support.
- Serve as biometrics functional lead on cross-functional teams to shape study design, statistical strategy, endpoint selection, and key decisions.
- Advise senior leadership on statistical methodologies, data strategy, data integrity, and clinical development planning.
- Oversee design, analysis, and interpretation of clinical trials and preclinical studies with scientific rigor, regulatory compliance, and high-quality data.
- Oversee SAPs, TLFs, CSRs, integrated summaries, and regulatory submission deliverables.
- Ensure deliverables meet regulatory and industry best practices (CDISC, SDTM, ADaM).
- Support regulatory interactions/inspections; represent Biometrics with FDA, EMA, and other authorities as appropriate.
- Oversee CRO/vendor deliverables (database build, CRF design, data review, programming outputs, TLF production).
- Establish biometrics systems, standards, processes, and SOPs; drive innovation in statistical methods and technology-enabled processes.
Education and Qualifications:
- PhD in Biostatistics, Statistics, or related quantitative discipline (required).
- 15+ years in biotech/pharma drug development with significant biometrics leadership.
- Experience leading integrated biometrics across Biostatistics, Statistical Programming, and Clinical Data Management.
- Deep knowledge across drug development phases, ideally early-stage through registration/commercialization support.
- Strong oncology background; immunology/autoimmune experience highly desirable.
- Experience with regulatory submissions (e.g., NDA/BLA) and health authority interactions.
- Strong expertise in adaptive design/statistical methodology and ICH/FDA/EMA/GCP requirements.
- Technical skills: SAS, R, CDISC, EDC systems, modern clinical data platforms.
- Proven ability to build/mentor/scale teams; executive communication and influencing skills.
- Ability to operate hands-on in a fast-paced environment; strong organization and ability to manage multiple programs.
- Travel up to 25%.
Benefits:
- Annual bonus program; incentive stock option plan; 401k plan; comprehensive medical (90–100% employer-paid premiums); dental/vision; HSA/FSA; supplemental insurance; unlimited PTO; generous holiday schedule; relocation assistance.