Biostatistician III # 26-19068

• The Statistical Sciences Contractor will support the execution of the PULSE check (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 PULSE check 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.

Duration: 12 Months

• The Statistical Sciences Contractor will support the execution of the PULSE check (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 PULSE check 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.

• Responsible for overseeing all aspects of statistical planning and analyses for clinical programs; directs both internal and external SAS programming efforts related to the responsible clinical programs. MA or Ph.D. in (Bio) statistics. Requires 5 to 7 years of experience in pharmaceutical or biotechnology industry.
• Must have experience preparing analysis programs for clinical trials phases I-III. Must have been primary statistician on at least one NDA/BLA. Must have sound knowledge of statistical applications for clinical trials.
• Excellent writing and communication skills, and knowledge and skills of programming important. Strong knowledge of and experience in clinical trials design.
• Very good knowledge of drug development regulations pertinent to trial design and statistical analysis.

• Master's degree or PhD in Statistics, Biostatistics, Data Science, Mathematics, Epidemiology, or a related quantitative field.
• Strong understanding of statistical methodologies and clinical trial data analysis.
• Experience with statistical programming in R (SAS experience is a plus).
• Experience analyzing complex datasets and translating findings into actionable insights.
• Ability to conduct exploratory analyses, interim analyses, and data monitoring activities.

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