Staff Biostatistician

Responsibilities

• Perform in a lead Biostatistician role providing technical expertise for high complexity clinical studies
• Provide expert level statistical guidance for innovative study design and clinical development plans
• Develop statistical sections of study protocols for clinical studies
• Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents
• Conduct overall statistical review of TFLs for clinical studies
• Manage operations with internal statistical programmers to ensure quality of deliverables
• Represent Biostatistics in interactions with regulatory authorities like the FDA
• Support the preparation of abstracts, manuscripts, and written reports
• Create, maintain, and implement SOPs and processes to ensure compliance and efficiency

Requirements

• Master's degree or higher in Statistics, Biostatistics, or Math
• 10+ years of lead project work as a statistician on clinical trial projects
• Expert understanding of biostatistics processes and clinical trial design
• Strong programming skills in R (required)
• Proficiency with literate programming such as R markdown or Sweave
• Proven project management leadership skills

Preferred Qualifications

• Ph.D. in Statistics, Biostatistics, or Math
• Experience leading IVD clinical Biostatistics to FDA submission
• Knowledge of CDISC requirements
• Proficiency in Python

About the Company

Freenome is working to change the landscape of early cancer detection through innovative in vitro diagnostic products.