Biostatistician - Remote

About the role

The Statistical Sciences Contractor will support the execution of the PULSEcheck (Progressive Uptake of Live Scientific Evaluation) initiative by partnering with study teams to monitor ongoing clinical trials and generate timely, data-driven insights. This role will focus on reviewing accumulating clinical trial data, evaluating predefined PULSEcheck criteria, conducting exploratory analyses, and supporting informed decision-making throughout study execution. The contractor will work closely with study statisticians, programmers, and cross-functional stakeholders to assess study progress, identify emerging trends and risks, and provide analytical support that enhances trial oversight while maintaining scientific rigor.

Responsibilities

• Review accumulating clinical trial data and evaluate predefined PULSEcheck criteria
• Conduct exploratory analyses and support informed decision-making throughout study execution
• Assess study progress and identify emerging trends and risks
• Provide analytical support that enhances trial oversight while maintaining scientific rigor
• Oversee all aspects of statistical planning and analyses for clinical programs
• Direct both internal and external SAS programming efforts related to responsible clinical programs
• Prepare analysis programs for clinical trials phases I-III

Qualifications

• Master's degree or PhD in Statistics, Biostatistics, Data Science, Mathematics, Epidemiology, or a related quantitative field
• 5 to 7 years of experience in pharmaceutical or biotechnology industry
• Must have been primary statistician on at least one NDA/BLA
• Strong understanding of statistical methodologies and clinical trial data analysis
• Experience analyzing complex datasets and translating findings into actionable insights
• Ability to conduct exploratory analyses, interim analyses, and data monitoring activities
• Sound knowledge of statistical applications for clinical trials
• Strong knowledge of and experience in clinical trials design
• Very good knowledge of drug development regulations pertinent to trial design and statistical analysis

Skills

• Statistical programming in R (SAS experience is a plus)
• Excellent writing and communication skills
• Programming knowledge and skills

Pay

$70.00 - 80.00 per hour

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
• Paid vacation time
• Paid parental leave
• Paid holidays annually

Schedule

Standard business hours