Job Description

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.