
Vaccine Data Analyst
2 weeks ago
This role offers statistical support for projects in the Vaccines Therapeutic Area.
Key Responsibilities
- Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in support of publication projects and regulatory query responses.
- Develop statistical analysis plans, mock-up tables, and quality check plans.
- Oversee programming support activities for assigned projects. Validate the accuracy, consistency, and integrity of the statistical output displays generated by programmers.
- Lead multiple project teams by applying project management skills, statistical, and programming techniques to prepare, execute, report, and document high-quality statistical analyses per statistical analysis plans.
- Conduct peer review of project-related work performed by other statisticians, maintain compliance with the latest regulatory requirements, and maintain project documentation and files according to departmental policy.
- Communicate competently and independently with clients to coordinate the statistical and programming considerations of the project.
- Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.
Requirements
- Masters in Statistics/Biostatistics (or related field) with 8+ years' experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 4+ years' experience in clinical trials.
- Effective verbal and written communication skills.
- Understanding of broad statistical theory and its application.
- Able to fully understand clinical questions and concepts and translate them into SAP development followed by data generation all the way through publication.
- Effective at clearly explaining statistical concepts to colleagues without statistical training.
- Work collaboratively as a team member.
- Experience with statistical modelling of clinical data and statistical inference.
- Experience in R or SAS programming languages.
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