Job Description
Remote, Senior/Principal Biostatistician (long-term FSP) We are seeking a Biostatistician to independently support multiple ongoing clinical trials within a Neuroimmunology Program. This role will be responsible for day-to-day statistical operations including safety monitoring, data review, reporting, and cross-functional collaboration to ensure successful study execution from protocol through CSR completion. Education & Experience • Master’s degree in Biostatistics/Statistics with 4-6 years pharmaceutical/biotech/CRO experience, or PhD in Biostatistics/Statistics with 2-4 years industry experience • Demonstrated experience as primary or lead statistician on at least 2-3 clinical studies (any phase) Technical Skills • Proficiency in SAS for clinical trial analysis and statistical programming review • Solid understanding of CDISC standards (SDTM, ADaM) with ability to review and approve ADaM specifications and datasets • Familiarity with clinical EDC systems (Medidata Rave, Veeva Vault, or similar) • Working knowledge of R for exploratory analysis and visualization Clinical Trial Experience • Independent execution of day-to-day statistical activities for ongoing trials • Experience across study lifecycle: protocol development through CSR completion • Experience writing statistical sections for protocols, SAPs, and CSRs • Experience with safety data monitoring and adverse event analysis • Knowledge of ICH-GCP guidelines, FDA/EMA regulatory requirements Operational • Proven track record managing multiple concurrent studies independently • Strong organizational skills with attention to detail in documentation, timelines, and implementation • Ability to troubleshoot data issues and drive resolution with cross-functional teams • Experience reviewing and providing feedback on programming deliverables (ADaM datasets, TLFs, validation outputs) Plus • Experience with early-phase trials (Phase I/II), particularly dose-escalation or First-in-Human studies • Ability to thrive in fast-paced environments where statistical insights directly impact study conduct decisions • Therapeutic area knowledge in neurology or immunology Apply tot his job