Executive Director, Statistical Programming
Core
Provide strategic and operational leadership for statistical programming across clinical development programs, ensuring rigorous quality review of deliverables and establishing scalable standards.
Role type
Executive Director, Statistical Programming
Builds
Regulatory submission deliverables (BLA/IND) and clinical trial analysis packages
Domain
Biotechnology / Ophthalmology / Gene Therapy
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
SAS programming (BASE, Macros, STAT, ODS, SQL), CDISC standards (SDTM, ADaM, CDASH), regulatory submission strategy, vendor oversight, team leadership
Preferred skills
R programming, ophthalmology domain expertise, biologic/gene therapy experience, P21 checks, Microsoft Office advanced features
Technologies
SAS, R, CDISC, eCTD, XPT, P21
Responsibilities
Lead statistical programming strategy for assigned indications; review statistical analysis plans; ensure audit-ready documentation; develop reusable code and standards; partner with IT on computing infrastructure; oversee biometrics vendors; ensure quality of outsourced deliverables; establish SOPs and continuous improvement initiatives.
Seniority
Executive, strategic leadership & team management