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