Principal Statistician
Job Summary
Seeking a skilled Principal Statistician for a remote contract position, the expert will perform independent statistical reviews, ensure data integrity for NDA submissions, and oversee an unblinded statistical team while collaborating with cross-functional groups.
Key responsibilities
- Perform independent statistical reviews and quality control on Phase III analysis outputs and datasets
- Oversee the unblinded statistical team to meet project timelines and collaborate with Medical Writing and Regulatory teams
- Review and ensure compliance of SDTM and ADaM datasets for submission readiness
Required qualifications
- MS or PhD in Statistics, Biostatistics, or a related quantitative discipline
- Hands-on experience in statistical review and quality control
- Strong SAS programming skills with the ability to troubleshoot independently
- Knowledge and experience with CDISC standards, including SDTM and ADaM
- Experience in blinded and unblinded clinical trial environments
Complete Job Description
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