Position SummaryOur client is seeking a senior-level Statistical Programming Consultant to support audit and inspection readiness for upcoming EMA and BLA filings. This role will partner closely with the Senior Director of Statistical Programming and serve as a key contributor in preparing for and leading/supporting regulatory inspections.This is not a traditional hands-on programming role. While a strong statistical programming background is required, this individual would have moved beyond pure study programming and repeatedly supported or led inspection readiness efforts. The primary focus will be inspection readiness, audit support, cross-functional communication, and leadership engagement. The ideal consultant is confident, proactive, and trusted by leadership to represent programming during high-stakes regulatory interactions.Key ResponsibilitiesLead and support EMA and BLA inspection readiness activities, including preparation, execution, and follow-upAct as a key programming subject matter expert during regulatory inspections and auditsSupport and advise the Senior Director of Statistical Programming on inspection strategy and readinessPrepare programming teams and leadership for inspection-related questions and interactionsCollaborate cross-functionally with QA, Regulatory Affairs, Clinical, Biometrics, and other stakeholdersReview and assess programming documentation, processes, and outputs for inspection readinessRespond to inspection questions related to programming, data traceability, and submission standardsProvide as-needed statistical programming support, review, or troubleshooting (secondary responsibility)Communicate clearly and confidently with senior management and regulatory inspectorsRequired Qualifications10-15+ years of industry experience and prior experience acting as a primary or key inspection readiness leadExtensive experience supporting EMA and/or BLA inspections and auditsSenior-level statistical programming background (e.g., former Lead / Managing Programmer or equivalent)Strong knowledge of CDISC standards (SDTM/ADaM) and submission programmingDemonstrated experience interfacing with management during inspections or auditsProven ability to work cross-functionally beyond biometricsExcellent verbal and written communication skillsComfortable operating in a consulting/advisory capacity, leading without formal authorityPreferred QualificationsExperience supporting both US FDA and EMA inspectionsBay Area local or able to travel onsite as needed