Principal Biostatistician

Position Summary

The Principal Biostatistician is the subject matter expert in design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data.

• Lead as statistician for one or more clinical programs from study design through regulatory submission.
• Design clinical trials (sample size, interim analyses, DMC activities, randomization).
• Develop statistical methodology for clinical protocols and clinical study reports.
• Create/review Statistical Analysis Plans (SAPs), including methodology and interim analysis strategies.
• Oversee creation/validation/traceability/reproducibility/maintenance of analysis datasets and statistical outputs.
• Lead electronic regulatory submissions of clinical trial data.
• Partner with clinical, regulatory, data management, and medical affairs to align statistical approaches.
• Lead data standardization (e.g., CRF/database design, edit checks, CDISC STDM/ADaM, e-submissions) and maintain SOPs/process improvements.
• Communicate complex statistical concepts to non-statistical stakeholders.
• Mentor/train junior staff; participate on clinical study teams; stay current on new trial designs/methodologies.

• BS in Statistics/Biostatistics + 10+ years relevant experience OR MS + 8+ years.
• 5+ years as a Biostatistician in biotech/pharma.
• Lead Biostatistician experience on several concurrent projects.
• Experience with CDISC STDM/ADaM required.

• Knowledge of clinical research, GCP, and regulatory requirements.
• Adaptive and/or Bayesian methods or complex innovative designs.
• Proficient in SAS; familiar with nQuery or PASS.
• Strong analytical skills; excellent English written/verbal communication.