Website Stemta Corporation
This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization. The Biostatistician will be involved in the design, execution, analysis, and reporting clinical studies with a focus on their clients’ infectious disease programs.
• Serve as the biostatistician in multiple infectious diseases clinical development teams responsible for all clinical study biostatistics deliverables with high quality and on time
• Responsible to bring innovative statistical thinking and methods to help drive applications of excellent statistical methods that increase the probability of successes for clinical development programs
• Develop statistical sections of protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses
• Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence
• Contribute to SOPs and/or Work Instructions related to biostatistics practices
• Collaborate with and manage internal and external functions
• MS or PhD (or equivalent degree) with 5+ years (PhD) or 7+ years (MS) of relevant work experience in Biotech, Pharma, or Clinical Research Organizations
• Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
EEO – M/F/D/V