Biostatistician

BiostatisticianAlzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer's disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer's clinical candidate, ALZ-801, is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer's disease-modifying therapy a reality for patients and their families, in a few short years.Alzheon is seeking a doctoral-level Biostatistician to serve as a statistical lead on regulatory interactions and clinical studies in Alzheimer's disease. The position spans the full study lifecycle: contributing to design and endpoint selection at the protocol stage, authoring statistical analysis plans, overseeing analysis execution and vendor deliverables, and supporting the interpretation and reporting of results to internal governance, regulatory agencies, and the scientific community.This is a submission-facing role. Alzheon's near-term statistical work is oriented toward FDA interactions, and the person in this position will own the statistical content that goes into those packages. Trials in neurodegeneration are also statistically unforgiving: progression is slow, endpoints are composite and noisy, dropout is rarely uninformative, and follow-up is long. We are looking for a statistician who has worked in that setting, or in an equally demanding one, and who can defend design choices to a regulator with evidence rather than convention.Key Responsibilities:Serve as lead statistician on assigned studies, from protocol concept through clinical study report and regulatory responseContribute to trial design, including endpoint and estimand selection, randomization and stratification schemes, sample size and power calculations, and interim analysis strategyIn partnership with external vendors, author statistical analysis plans, table and figure shells, and randomization specifications, and review case report forms and data management plans for analytic implicationsSpecify and validate analyses of longitudinal outcomes, including mixed models for repeated measures, and address missing data under clearly stated assumptions with appropriate sensitivity analysesOversee CRO statistical deliverables, including independent verification of key results, and hold vendors to CDISC SDTM and ADaM standardsPrepare materials for and support interactions with Data Safety Monitoring Boards and steering committeesAuthor the statistical sections of protocols, briefing books, clinical study reports, manuscripts, and congress presentationsProvide statistical input to biomarker, pharmacokinetic, and exploratory subgroup analyses in collaboration with translational and clinical colleaguesRegulatory and Submission Focus:Own the statistical content of FDA submissions, including the Summary of Clinical Efficacy, the Integrated Summary of Efficacy and Integrated Summary of Safety, and the statistical sections of Module 2 and Module 5 of the eCTDPrepare for and participate in agency interactions across the development lifecycle, including End-of-Phase 2, Type B and Type C meetings, and pre-NDA meetings, drafting the statistical questions and the supporting position that accompanies themLead the statistical response to agency information requests during review, working to the short turnaround times those requests carryEnsure submission-readiness of analysis datasets and documentation, including ADaM and SDTM conformance, define.xml and the analysis data reviewer's guide, and reproducibility of every submitted result from source dataApply FDA and ICH guidance to design and analysis decisions, including ICH E9(R1) on estimands, guidance on multiple endpoints and multiplicity, adaptive design, and the handling of missing data in confirmatory trialsSupport Advisory Committee preparation and other pre-approval activities, including mock panel questions and sensitivity analyses anticipating reviewer challengesRequirements:PhD in Biostatistics or Statistics; a closely related quantitative graduate degree with equivalent training will be consideredExperience as a statistician on interventional clinical trials, including at least one study in which the candidate held lead statistical responsibilityExperience in neurology, neurodegeneration, psychiatry, or another CNS indication, with working knowledge of cognitive, functional, and global outcome measuresDirect contribution to an NDA, BLA, or comparable marketing application, or to a major agency interaction such as an End-of-Phase 2 or pre-NDA meeting, with responsibility for statistical contentStrong applied command of longitudinal and repeated-measures methods, estimands under ICH E9(R1), missing data methodology, and multiplicity controlExpert-level SAS or R programming, including the ability to independently reproduce and audit an external vendor's analysisWorking knowledge of CDISC standards and of regulatory expectations for statistical documentation in marketing applicationsExcellent written communication and the ability to explain statistical reasoning to clinicians, executives, and other non-statisticians without diluting itPreferred Qualifications:Direct experience with Alzheimer's disease trials and instrument-based endpoints such as ADAS-Cog or CDR-SBExperience with adaptive designs, Bayesian methods, or disease progression modelingExperience with FDA Advisory Committee preparation, post-marketing commitments, or accelerated approval pathwaysPublication record in statistical methodology or in clinical trial resultsExperience mentoring junior statisticians or statistical programmersAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.