Kaztronix
Vice President, Biometrics
The Vice President, Biometrics, is a key member of the R&D leadership team and is responsible for providing strategic, scientific, and operational leadership for all biometrics functions, including Biostatistics, Statistical Programming, and Clinical Data Management. This leader will ensure the generation of high-quality clinical data to support development decisions, regulatory authority submissions, publications, and commercialization efforts. The role requires cross-functional collaboration, strong regulatory engagement, and visionary leadership to build scalable biometrics capabilities that align with the company's mission and growth objectives.
Key Responsibilities • Define and execute the biometrics strategy in alignment with clinical development, regulatory, and corporate goals. • Act as a thought leader and internal consultant on statistical and data-related topics across the pipeline. • Provide critical input into clinical development strategies, including endpoint selection, adaptive design considerations, and integrated evidence plans.
Operational Oversight • Lead and manage Biostatistics, Statistical Programming, and Data Management teams across all stages of clinical development. • Oversee the development of statistical analysis plans (SAPs), mock shells, and data presentation standards. • Drive innovation in biometrics methodologies and tools, including advanced analytics, real-world data integration, and digital biomarker strategies.
Regulatory Support • Represent Biometrics in regulatory interactions, including FDA, EMA, and other global agencies, and in advisory committee preparation. • Oversee the development of regulatory submission packages (e.g., ISS/Client, CSR outputs, and electronic data submission packages including CDISC).
Vendor and Resource Management • Develop and execute vendor strategy for biometrics services, ensuring cost-effective and high-quality partnerships. • Monitor CRO/vendor performance, budgets, timelines, and deliverables. • Optimize resource allocation, operational efficiency, and risk mitigation for internal and outsourced activities.
Cross-Functional Collaboration • Partner with Clinical Operations, Regulatory Affairs, Medical Affairs, RWE, and IT to ensure data integrity, compliance, and strategic alignment. • Contribute to due diligence evaluations and integration planning for business development or licensing opportunities. • Ensure that all biometrics deliverables are completed in accordance with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements. • Champion process improvement initiatives and best practices to enhance data quality and efficiency.
People Leadership • Build, lead, mentor, and inspire a high-performing, agile biometrics organization. • Foster a culture of scientific excellence, accountability, inclusion, and continuous learning.
Qualifications, Experience & Competencies • PhD or Master's degree in Biostatistics, Statistics, Mathematics, or a related field • Minimum 15 years of experience in biometrics roles within the pharmaceutical or biotechnology industry • At least 8 years in leadership or management roles overseeing biostatistics, programming, and/or data management functions • Proven experience supporting regulatory submissions, including NDAs/BLAs or MAAs • Deep understanding of CDISC standards (SDTM, ADaM), clinical trial design, and statistical methodologies • Demonstrated success in building and leading high-performing teams in a matrix environment • Strong vendor management and outsourcing strategy experience • Excellent communication, strategic thinking, and stakeholder engagement skills • Competencies: Learning agility, critical thinking, collaborative team player and leader, operational excellence, results-driven
The Vice President, Biometrics, is a key member of the R&D leadership team and is responsible for providing strategic, scientific, and operational leadership for all biometrics functions, including Biostatistics, Statistical Programming, and Clinical Data Management. This leader will ensure the generation of high-quality clinical data to support development decisions, regulatory authority submissions, publications, and commercialization efforts. The role requires cross-functional collaboration, strong regulatory engagement, and visionary leadership to build scalable biometrics capabilities that align with the company's mission and growth objectives.
Key Responsibilities • Define and execute the biometrics strategy in alignment with clinical development, regulatory, and corporate goals. • Act as a thought leader and internal consultant on statistical and data-related topics across the pipeline. • Provide critical input into clinical development strategies, including endpoint selection, adaptive design considerations, and integrated evidence plans.
Operational Oversight • Lead and manage Biostatistics, Statistical Programming, and Data Management teams across all stages of clinical development. • Oversee the development of statistical analysis plans (SAPs), mock shells, and data presentation standards. • Drive innovation in biometrics methodologies and tools, including advanced analytics, real-world data integration, and digital biomarker strategies.
Regulatory Support • Represent Biometrics in regulatory interactions, including FDA, EMA, and other global agencies, and in advisory committee preparation. • Oversee the development of regulatory submission packages (e.g., ISS/Client, CSR outputs, and electronic data submission packages including CDISC).
Vendor and Resource Management • Develop and execute vendor strategy for biometrics services, ensuring cost-effective and high-quality partnerships. • Monitor CRO/vendor performance, budgets, timelines, and deliverables. • Optimize resource allocation, operational efficiency, and risk mitigation for internal and outsourced activities.
Cross-Functional Collaboration • Partner with Clinical Operations, Regulatory Affairs, Medical Affairs, RWE, and IT to ensure data integrity, compliance, and strategic alignment. • Contribute to due diligence evaluations and integration planning for business development or licensing opportunities. • Ensure that all biometrics deliverables are completed in accordance with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements. • Champion process improvement initiatives and best practices to enhance data quality and efficiency.
People Leadership • Build, lead, mentor, and inspire a high-performing, agile biometrics organization. • Foster a culture of scientific excellence, accountability, inclusion, and continuous learning.
Qualifications, Experience & Competencies • PhD or Master's degree in Biostatistics, Statistics, Mathematics, or a related field • Minimum 15 years of experience in biometrics roles within the pharmaceutical or biotechnology industry • At least 8 years in leadership or management roles overseeing biostatistics, programming, and/or data management functions • Proven experience supporting regulatory submissions, including NDAs/BLAs or MAAs • Deep understanding of CDISC standards (SDTM, ADaM), clinical trial design, and statistical methodologies • Demonstrated success in building and leading high-performing teams in a matrix environment • Strong vendor management and outsourcing strategy experience • Excellent communication, strategic thinking, and stakeholder engagement skills • Competencies: Learning agility, critical thinking, collaborative team player and leader, operational excellence, results-driven