Job Summary

A company is looking for a Senior Biostatistician to lead and/or support clinical trials in the field of Oncology.

Key Responsibilities:

• Provide statistics input throughout the clinical trial process, including protocol development, review of statistical analyses, and preparation of reports
• Contribute to the development and review of statistical analysis plans, TFL shells, and specifications for programmers
• Review ADaM and SDTM datasets and ensure their accuracy

Required Qualifications:

• Master's or PhD in Biostatistics or related field
• 5+ years of experience in clinical trials, with experience as a clinical study lead
• Good knowledge of SAS programming and ability to verify statistical output
• Experience in Oncology clinical trials, including ADaM knowledge, SAP development, and CSR writing
• Familiarity with pharmaceutical industry and regulatory requirements for drug development