Senior Biostatistician

Remote position. If interested, please send profiles to shobhana.bansal@ephicacy.com

Job Description

• Lead study design, protocol development, statistical analysis and results reporting and interpretation 
• Work within cross-functional teams including data managers, medical writers, research managers, engineers, medical directors and regulatory staff for regulatory submission 
• Manage internal and external statistics and programming resources for deliverables 
• Develop/review statistical analysis plan, table shells, analysis dataset specifications, and study reports 
• Review case report forms (CRF), database set up, and clinical study report (CSR) 
• Meet with regulatory authorities including FDA and CFDA, and DSMB committees  
• Overs activities of statistics, statistical programming and data management 
• Ensure quality and timeliness of analysis output and reporting 
• Oncology experience a must 
• Develop and implement statistical analysis plans for clinical trials including experimental design, sample size calculations, randomization, and methods of analysis 
• Develop specifications for statistical tables, figures and listings                              
• If needed, review SAS programs for analysis of clinical trial data and interpreted results 
• Review and verify the reports match study protocols 
• Attend Data Monitoring Committee (DMC) meeting as unblinded biostatistician 
• Work with sponsors and co-workers from other internal departments to resolve issues 
• Mentor junior co-workers on statistical and programming issues 
• Ph.D. in related field with 5 or more years of experience or a Master’s degree with 8 or more years of experience preferred