Sr. Director, Biostatistics

Senior Director Of BiostatisticsWe are seeking an experienced and strategic Senior Director of Biostatistics to provide statistical leadership across oncology clinical development programs, with strong expertise in Phase 3 registrational studies, adaptive clinical trial design, and companion diagnostic (CDx) development. The successful candidate will play a critical role in advancing precision medicine strategies through innovative trial methodologies, biomarker-driven development, and global regulatory engagement.This position requires extensive experience in oncology drug development, late-stage clinical trial strategy, adaptive designs, biomarker and CDx co-development, and regulatory submissions. The Senior Director will collaborate closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Affairs, Data Management, Statistical Programming, Clinical Operations, and external partners.Primary Responsibilities And DutiesClinical Development & Statistical LeadershipProvide strategic statistical leadership for oncology programs from early development through registration and lifecycle management.Lead statistical design and execution of Phase 1–3 oncology clinical trials, with substantial emphasis on registrational Phase 3 studies.Develop innovative and efficient clinical trial designs, including:Adaptive designsBiomarker-enrichment strategiesBasket, umbrella, and platform trialsProvide statistical guidance on:Endpoint selection and multiplicity controlEstimand strategyMissing data methodologySensitivity analysesContribute to:Clinical development plansProtocolsStatistical analysis plans (SAPs)Clinical study reports (CSRs)Regulatory briefing packagesPublications and scientific presentationsAdaptive Design & Statistical InnovationLead development and evaluation of adaptive design methodologies using simulation-based approaches.Conduct or oversee statistical simulations evaluating:Operating characteristicsType I error controlStatistical powerFutility and efficacy boundariesAdaptive enrichment strategiesPartner with programming teams to develop simulation frameworks in R and/or SAS.Communicate complex adaptive design concepts effectively to cross-functional teams and regulatory agencies.Regulatory & Submission LeadershipLead statistical support for:End-of-Phase 2 meetings or Type B meetingsScientific advice meetingsNDA/BLA submissionsProvide strategic input on:Alpha allocation/multiplicity adjustmentInterim/final data analysesIDMC/DMC supportBenefit-risk assessmentsEnsure compliance with ICH, FDA, EMA, and global regulatory guidance for both therapeutics and diagnostics.Cross-Functional & Organizational LeadershipFunction as a core member of oncology program teamsMentor and provide technical leadership to statisticians and programmers.Oversee CROs and external statistical vendors.Drive adoption of statistical standards, innovative methodologies, and data quality best practices.Support business development, due diligence, and portfolio strategy activities.QualificationsEducation:PhD or MS in Biostatistics, Statistics, or related quantitative discipline. PhD strongly preferred.Experience:Typically: PhD with 12+ years of biotechnology/pharmaceutical industry experience, or MS with 15+ years of industry experience.Extensive oncology drug development experience required.Demonstrated leadership in Phase 3 registrational oncology trials.Strong experience with adaptive clinical trial designs and simulation methodologies.Experience supporting companion diagnostic (CDx) co-development programs and biomarker-driven development strategies.Prior experience with global regulatory submissions and health authority interactions required.Biotech industry experience strongly preferred.Technical Expertise:Strong knowledge of:Oncology clinical trial methodologySurvival analysis and time-to-event endpointsMultiplicity adjustment and alpha controlGroup sequential and adaptive methodologiesBayesian and frequentist approachesBiomarker-driven clinical developmentEstimands frameworkMissing data methodologyInterim monitoring and IDMC supportCompanion diagnostic statistical methodologiesProficiency in:SASREAST, ADDPLAN, or similar adaptive design software preferredLeadership Style:Strategic and innovative thinker with strong scientific judgmentExcellent communication and influencing skillsAbility to explain complex statistical concepts to technical and non-technical stakeholdersStrong collaboration and stakeholder management capabilitiesProven ability to lead in a fast-paced biotechnology environmentPreferred ExperienceImmuno-oncology and targeted therapy developmentCompanion diagnostic (CDx) co-development and PMA supportPrecision medicine and biomarker-enriched development programsGlobal multi-regional clinical trialsAccelerated approval pathwaysSalary Range:$240,000 - $280,000 DOEPhysical Demands:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.Ability to communicate in written and oral forms.Must be able to interact and communicate in written and oral forms with a diverse group of individuals on both technical and business topics.The ability to sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.Must be able to travel 25% of the time without restriction, domestically and/or internationally.Must be able to use the telephone and communicate clearly with a host of external individuals, domestically and globally.Ability to work at a computer for extensive periods of time.Ability to work in a fast-paced working environment managing multiple tasks.Work Environment And Environmental Conditions:We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.ALX Oncology is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.About ALX Oncology:ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.For more information about us, please visit www.alxoncology.