Associate Director Statistical Programming

We're partnering with a well-funded biotech client to identify an Associate Director of Statistical Programming to support a growing biometrics function across late-stage clinical development.The RoleThis is a senior individual contributor position responsible for programming strategy and execution across multiple studies. You'll serve as a technical lead and key interface between biostatistics, data management, and clinical operations — with high visibility into regulatory deliverables.What You'll OwnEnd-to-end programming strategy for clinical trials from study startup through regulatory submissionCDISC standards implementation (SDTM, ADaM) and TLF productionOversight and quality management of outsourced programming resourcesDirect contribution to submission-ready deliverables (ISS/ISE, NDA/BLA packages)Process improvement initiatives — automation, macro libraries, standardization across studiesTechnical mentorship of junior and mid-level programmersWhat We're Looking For10+ years in statistical programming within pharma, biotech, or CRO environmentsDeep SAS expertise; working knowledge of R and/or Python is a plusDemonstrated experience supporting FDA submissions (NDA, BLA, or sNDA)Strong understanding of CDISC standards and regulatory expectationsExperience managing CRO programming vendors and holding them accountable on quality and timelinesClear communicator who can translate technical programming decisions for cross-functional stakeholdersWhy This OpportunityHigh-impact IC role with direct line of sight to regulatory milestonesWell-funded pipeline with meaningful late-stage activityOpportunity to shape programming standards and infrastructure from the ground up