Senior Biostatistician

Job Summary

Key Responsibilities

• Review and analyze accumulating clinical trial data to evaluate study progress and performance metrics.
• Conduct exploratory, interim, and monitoring analyses to identify trends, risks, and opportunities.
• Partner with study statisticians, programmers, and cross-functional teams to support trial oversight activities.
• Develop and execute statistical analysis plans for clinical research studies.
• Provide timely statistical insights and recommendations to support study execution and decision-making.
• Support statistical planning and analysis activities across clinical development programs.
• Cook up with internal and external programming teams to ensure accurate and efficient data analyses.
• Maintain compliance with applicable regulatory and scientific standards throughout study execution.
• Communicate analytical findings through reports, presentations, and technical documentation.

Required Qualifications

• Master’s degree or Doctorate in Statistics, Biostatistics, Data Science, Mathematics, Epidemiology, or a related quantitative discipline.
• Minimum 5 years of experience in the pharmaceutical, biotechnology, or clinical research industry.
• Strong knowledge of statistical methodologies and clinical trial data analysis.
• Experience with statistical programming using R.
• Experience preparing analysis programs for Phase I, Phase II, and Phase III clinical trials.
• Strong understanding of clinical trial design and statistical applications within clinical research.
• Ability to analyze complex datasets and translate findings into actionable business and scientific insights.
• Excellent written, verbal, and technical communication skills.
• Experience conducting data monitoring, interim analyses, and exploratory analyses.

Preferred Qualifications

• Doctorate in a quantitative discipline.
• Experience using SAS for clinical data analysis.
• Experience serving as a lead or primary statistician for regulatory submissions.
• Knowledge of drug development regulations and statistical requirements supporting clinical research programs.
• Experience supporting New Drug Application or Biologics License Application submissions.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term disability insurance
• Short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time
• Hours of paid vacation time
• Weeks of paid parental leave
• Paid holidays annually

Pay Range

$70 - $85 per hour (depending on experience)