Job Description

Responsibilities:

• Provide technical leadership and collaborate with stakeholders through the design and conduct clinical validation studies
• Lead development on statistical analysis plans - data QC check, sample size and power calculations, and propose accurate and efficient statistical methodologies
• Execute the study analysis, interpret the analysis results, and collaborate with stakeholders to write the study report and publication
• Provide statistical supports that are required for the submissions and review process
• Independent working on complex problems, and selecting and adapting novel methods as appropriate
• It is a very interdisciplinary role, so working with other scientist and engineers to translate research into actionable insights for our clients
• While staying a float on the latest methodological advances in real world studies and clinical trials And complying with all regulations and Company procedures

Requirements:

• MS degree in Biostatistics/Statistics with 10 years of pharmaceutical clinical trial experience, or Ph.D. degree in Biostatistics/Statistics with 5+ years of pharmaceutical clinical trial experience
• Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA
• Programming skills in SAS and working knowledge of software such as nQuery, East, etc. to create ISS, Shells, TFLs, and Ad Hoc Analysis.
• Excellent analytical, written, and oral communication skills

Skills: