Remote Senior Biostatistician

Summary

The job is for a Senior Biostatistician who will manage complex studies and provide statistical representation. The role requires a Master's degree in biostatistics or a related field with at least 5 years of relevant experience in pharmaceutical research or CRO setting, preferably with experience in Oncology.

Requirements

• Master’s degree, equivalent, or higher in biostatistics or a related field
• A minimum of 5+ years of relevant work experience
• Previous experience in pharmaceutical research or CRO setting required
• Prior experience in multiple therapeutic areas required, with experience in Oncology preferred

Responsibilities

• Lead low to high complexity studies in various phases of development
• Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs
• Collaborate with internal and external project team personnel as needed to meet project deliverables and timelines for statistical data analysis and reporting
• Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies
• Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, and/or bid defense meetings
• Provide statistical advice/recommendations regarding clinical study design/study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, and document review/approval
• Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology
• Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures
• Ensure the quality and integrity of data analysis and reporting by programming checks using SAS
• Monitor project budgets as it relates to the scope of work and support project forecasting efforts