Statistical Consultant

Source One is a consulting services company and we’re currently looking for the following individual to work as a remote consultant to our direct client, a global medical device company. Job Title: Statistical Consultant Duration: 24 months 40 hours/week, Mon-Fri, 1st shift Job Description: - Lead the statistical design and analysis of projects, collaborating closely with cross-functional teams, to establish the conditions essential for determining safety, efficacy, and marketability of investigational products. - Review and contribute to study protocols, statistical analysis plans, and clinical study reports, adhering to regulatory guidelines and industry best practices. - Develop and implement advanced statistical methodologies and models, ensuring appropriate implementation to address project needs in one or more Therapeutic or Technology Areas. - Analyze and interpret clinical trial data, including efficacy and safety endpoints, and provide actionable insights to support decision-making. - Collaborate with statisticians, data scientists, and programmers to ensure the accurate and timely delivery of statistical outputs for regulatory submissions and scientific publications. - Conduct exploratory data analysis, including use of visualization and statistical techniques to identify trends, patterns, and potential safety signals in clinical trial data. - Participate in meetings with regulatory authorities, addressing statistical queries and providing necessary documentation for submissions. Minimum Requirements - Advance degree in Statistics or related discipline - At least 3 years’ experience supporting the design and analysis of clinical trials in a Medical Device or Pharmaceutical company - SAS programming experience is a must, R programming experience is a plus