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Associate Director, Statistical Programming

Apogee Therapeutics 🧬πŸ§ͺπŸ”¬
$185,000–$210,000
USD/year

Responsible for leading statistical programming activities to support various clinical trial projects, you'll build programming processes for clinical studies and submissions. Managing programmers and CROs, you will oversee programming activities and provide timely support to cross-functional teams on statistical programming matters.

We are seeking a Principal Programmer to ensure clinical data deliverables meet FDA regulatory requirements, CDISC standards, and the FDA Technical Conformance Guide (TCG). This position requires expertise in performing compliance and conformance checks for submission data packages. You will provide standardized guidance to biotech companies on FDA submission expectations.