Senior/Principal Biostatistician

By | January 7, 2026
  • Contract
  • Remote

SimulStat

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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

 

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