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r gcp version control fda 21 cfr part 11 cdisc sdtm📋 Description
- Build, mentor, and direct a high-performing statistical programming team.
- Provide strategic direction for the programming function and goals.
- Lead regulatory submissions (510(k), CTA/CDx, PMA) programming deliverables.
- Direct generation and validation of analysis datasets and TLFs.
- Lead development and validation of efficient R code; enforce standards.
- Manage scalable programming infrastructure for Biostatistics.
🎯 Requirements
- Minimum 10 years of clinical trials experience in diagnostics/biotech/pharma.
- At least 5 years leading a team.
- Advanced degree in Biostatistics, Statistics, Computer Science, or related field.
🎁 Benefits
- Competitive medical, dental, vision, life, and disability benefits.
- Free molecular testing for employees and their families.
- Fertility care benefits and parental leave options.
- 401(k) and commuter benefits.
- Generous employee referral program.
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