Director of Statistical Programming
Tasks
- Develop validate and review R code
- Direct generation and validation of analysis datasets and TLFs
- Lead statistical programming team
- Maintain programming infrastructure for biostatistics
- Partner with biostatistics clinical operations data management and regulatory
- Provide strategic direction for programming standards
- Serve as primary programming lead for regulatory submissions
Perks/Benefits
- 401k benefits
- Commuter benefits
- Employee referral program
- Fertility care benefits
- Free testing
- Medical dental vision life and disability plans
- Pregnancy and baby bonding leave
Skills/Tech-stack
21 CFR Part 11 | 510(k) | ADaM | CDISC | CFR Part 11 | CTA | DMP | Data Integrity | ECRF | FDA | FDA 21 CFR | FDA 21 CFR Part 11 | GCP | Genetics | ICH | ICH GCP | NGS | Oncology | PMA | Part 11 | R | Regulatory Submissions | SDTM | Statistical programming | Version control
Education
N/A
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