Source One is a consulting services company and were currently looking for the following individual to work as a remote consultant to our direct client, a global medical device company.
Job Title: Clinical Trial Statistician
Duration: 24 months
40 hours/week, Mon-Fri, 1st shift
This Clinical Trial Statistician will be assigned a series of trials first responsibility and will work with the team to develop clinical study protocol, authoring the statistical section of the protocol. Next, they will work with the data mgmt team to review and approve the CRF (Case Report Form). They will work with a Data Manager with data transfer agreements and outside vendors to make sure correct data is flowing in. They will determine who does and doesn't have access to the data and put together a randomization plan, which requires familiarity with the Veeva system. Additionally, will draft table shelves - hold review meetings, etc., review programmer work and output, and author any statistical section of the final report.
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
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