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Responsibilities:
- Build and mentor a statistical programming team to support clinical validation and utility of diagnostic tests.
- Act as the primary programming lead for regulatory submissions and ensure deliverables meet global standards.
- Direct the generation and validation of analysis datasets and TLFs, ensuring data integrity and compliance.
Qualifications:
- Minimum 10 years of industry experience in clinical trials within diagnostics or biotechnology.
- Advanced degree in Biostatistics, Statistics, Computer Science, or a related field.
- At least 5 years of experience leading a team.
Skills:
- Expert working knowledge of R for clinical trial reporting and maintaining statistical packages.
- In-depth knowledge of CDISC standards including SDTM and ADaM.
- Proven track record of producing high-quality analysis output for regulatory audiences.
Natera
Natera is a global leader in cell-free DNA testing focused on oncology, women's health, and organ health. The company consists of professionals from elite institutions who work collaboratively to change genetic disease management.