{"id":3709233,"url":"https://alion.io/job/rezolute-director-biostatistics","title":"Director – Biostatistics","company":{"id":689334,"name":"Rezolute","domain":"rezolutebio.com","url":"https://alion.io/company/rezolutebio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":75,"open_postings":4,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Early Careers","role_family":"Early Careers","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Redwood City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CDISC","optional":false},{"name":"ICH Guidelines","optional":true},{"name":"SAS","optional":true}],"status":"live","first_seen_at":"2026-11-03T19:15:18Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-04T12:30:47Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of congenital and acquired forms of hyperinsulinism (HI). Rezolute’s mission is to bring hope and meaningful solutions to patients and families affected by rare diseases through scientific innovation, collaboration, and integrity.\nPosition Summary\nWe are seeking an accomplished Director, Biostatistics to provide strategic and operational leadership for the statistical function within a growing, late-stage biopharmaceutical company. The organization currently has two Phase III clinical programs advancing toward regulatory submissions and commercialization, creating an exciting opportunity for a highly experienced statistician to influence development strategy, regulatory interactions, and submission readiness.\nThe Director, Biostatistics will serve as the lead statistical expert across clinical development programs, partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Statistical Programming, and external vendors. This individual will ensure the design, analysis, interpretation, and reporting of clinical trial data meet the highest scientific and regulatory standards.\nExperience in rare disease drug development and NDA/BLA submissions is strongly preferred.\nKey Responsibilities\nStatistical Leadership\nProvide strategic statistical oversight for Phase III clinical development programs and future lifecycle management activities.\nLead the development of statistical strategies supporting clinical development plans, regulatory submissions, and post-hoc analyses.\nServe as the statistical lead for one or more products and represent Biostatistics on cross-functional program teams.\nAdvise senior management regarding statistical considerations, development risks, and mitigation strategies.\nClinical Trial Design & Analysis\nLead the design and statistical methodology for Phase II, Phase III, and long-term extension studies.\nAuthor and review statistical sections of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), and submission documents.\nEnsure high-quality analysis of efficacy, safety, patient-reported outcomes, and biomarker data.\nOversee endpoint selection, estimands, multiplicity strategies, interim analyses, and adaptive design considerations where appropriate.\nRegulatory & Submission Support\nLead the statistical components of NDA/BLA/MAA submissions, including integrated efficacy and safety analyses, statistical documentation, responses to agency questions, and preparation for regulatory review and inspection.\nRepresent and defend statistical positions in interactions with global regulatory agencies, including FDA, EMA, MHRA, PMDA, and other health authorities.\nSupport preparation of briefing packages, meeting materials, and responses to regulatory questions.\nProvide statistical leadership for NDA/BLA/MAA submission activities and inspection readiness.\nEnsure compliance with ICH, FDA, EMA, and other relevant regulatory guidance.\nVendor & Functional Oversight\nManage and provide scientific and operational oversight of CROs, external biostatistics consultants, and statistical programming vendors.\nCollaborate closely with Statistical Programming to ensure analysis datasets, TLFs, and submission deliverables are generated according to CDISC standards.\nReview and approve key statistical deliverables to ensure quality, timelines, and regulatory compliance.\nCross-Functional Collaboration\nPartner with Clinical Development physicians, Clinical Operations, Data Management, Safety, and Regulatory Affairs to support program objectives.\nPresent statistical findings to senior leadership, advisory boards, investigators, and external stakeholders.\nMentor and develop junior statisticians and contribute to the growth of the Biometrics organization.\nQualifications\nEducation\nPh.D. in Statistics, Biostatistics, Mathematics, or related quantitative discipline preferred.\nMaster's degree with significant industry experience will be considered.\nExperience\n10+ years of biostatistical experience within the pharmaceutical, biotechnology, or CRO industry.\nExperience serving as lead statistician for late-stage clinical development programs.\nDemonstrated involvement in Phase III clinical trials and regulatory submissions.\nExperience supporting FDA and/or EMA interactions.\nRare disease development experience strongly preferred.\nPrior experience in a small or emerging biotechnology environment is highly desirable.\nTechnical Skills\nStrong comprehensive knowledge of clinical trial methodology, statistical theory, and regulatory requirements.\nExpertise in ICH E9, estimands framework, adaptive trial designs, longitudinal data analysis, multiplicity methodologies, and missing data strategies.\nWorking knowledge of CDISC SDTM and ADaM standards.\nFamiliarity with SAS and R programming environments.\nExperience reviewing outputs, analyses, and submission deliverables generated by statistical programming teams.\nLeadership Competencies\nStrategic thinker capable of balancing scientific rigor with business objectives.\nStrong communication and influencing skills across technical and non-technical stakeholders.\nComfortable operating in a fast-paced, resource-conscious biotechnology environment.\nDemonstrated ability to manage multiple priorities while meeting aggressive development timelines.\nCollaborative, hands-on leader willing to work at both strategic and operational levels.\nPreferred Experience\nRare disease, orphan drug, or ultra-rare disease development programs, analysis of continuous glucose monitoring in applicable therapeutic areas.\nExperience supporting NDA, BLA, or MAA submissions.\nExposure to accelerated approval pathways or breakthrough designation programs.\nExperience in a company transitioning from late-stage development to commercialization.\nPrior leadership of biometrics vendors and global development 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