Senior Biostatistician

Biostatistician III

Seeking an experienced Biostatistician III to support clinical development programs by analyzing ongoing clinical trial data and providing data-driven insights to study teams. This role will partner with statisticians, programmers, and cross-functional stakeholders to monitor study progress, evaluate predefined criteria, conduct exploratory analyses, and support informed decision-making throughout the clinical trial lifecycle.

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.
• Coordinate 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:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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, and paid holidays annually – as applicable.

Pay Range: $70 - $85 per hour (depending on experience)