Executive Director, Biostatistics (Oncology)

Executive Director, Biostatistics (Oncology)Location: Onsite – San Francisco Bay Area, CA **This position is onsite ONLY. Summary A rapidly growing, innovation-driven biotechnology organization is seeking an Executive Director of Biostatistics to lead statistical strategy and execution across a diverse oncology pipeline. This leadership role will oversee the design, analysis, and interpretation of clinical trials spanning Phase I–IV studies across multiple programs.The ideal candidate brings deep expertise in clinical trial methodology, regulatory expectations, and statistical applications in oncology drug development. This individual will serve as a strategic partner to cross-functional teams, ensuring robust study design, high-quality data delivery, and alignment with global regulatory standards.Key Responsibilities of the job: Provide strategic leadership for biostatistics across clinical development programsOversee statistical design, analysis, and reporting for Phase I–IV clinical trialsEnsure scientific rigor and regulatory compliance in protocols, analysis plans, and study outputsPartner cross-functionally with clinical development, regulatory, data management, and safety teamsGuide interpretation of clinical data and contribute to regulatory submissions and publicationsLead and mentor a team of statisticians, fostering development and high performanceEstablish and evolve departmental standards, processes, and best practicesDrive process improvements and standardization initiatives across biostatistics functionsManage external vendors, including CROs, ensuring quality, timelines, and budget adherenceParticipate in regulatory interactions with global health authorities (e.g., FDA, EMA)Support vendor selection processes, including RFP development and evaluationProvide proactive risk assessment and strategic input to support program successDirectly manage and develop biostatistics team membersInfluence cross-functional teams through matrix leadershipContribute to organizational strategy and functional excellenceRequired: PhD in Statistics/Biostatistics (or related field) with 14+ years of experience or MS in Statistics/Biostatistics (or related field) with 17+ years of industry experience.Significant experience in oncology clinical development requiredLeadership of late-stage (especially Phase III) oncology trialsExperience managing multiple programs and compounds simultaneouslyPrior interaction with global regulatory agenciesExperience overseeing CROs and external partnersTechnical ExpertiseStrong knowledge of clinical trial design, statistical methodologies, and data analysisFamiliarity with regulatory guidelines (FDA, EMA, ICH)Expertise in CDISC standards (SDTM, ADaM)Proficiency with statistical software (e.g., SAS, EAST, nQuery, Cytel or equivalent)Understanding of related functions including clinical operations, data management, and regulatory affairsCore CompetenciesStrategic thinking and problem-solving in complex environmentsStrong leadership, communication, and stakeholder management skillsAbility to manage competing priorities and deliver under tight timelinesExperience driving innovation and continuous improvementBusiness acumen combined with scientific rigorOperates at a senior leadership level with significant influence on clinical development strategyWorks on complex, high-impact programs requiring independent judgment and cross-functional collaborationRegular interaction with senior leadership and external partnersAccountable for timelines, budgets, and quality of deliverables***Must be willing to be ONSITE 5 days per week for this role******Position pays an excellent base salary plus bonus and stock, full benefits and other incentives.