Principal Biostatistician
Parexel
Senior Biostatistician – Vaccines
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in supporting publication projects and regulatory query responses
- Develop statistical analysis plan, mock-up tables, quality check plan
- 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 of high-quality statistical analysis per statistical analysis plans
- Conduct peer review of project related work performed by other statisticians, maintain compliance with the latest regulatory requirements, maintain project documentation and files according to departmental policy
- Communicate competently and independently with client to coordinate the statistical and programming considerations of the project
- Demonstrate 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 to translate and simplify 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
