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
- 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
Working experience and knowledge of FDA regulations and guidelines
Experience with version control and software testing
Experience supporting data science teams in model building and validation
Client facing or consulting exp
