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
