Job Details

Position Summary

Our 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 Responsibilities

• Lead and support EMA and BLA inspection readiness activities, including preparation, execution, and follow-up
• Act as a key programming subject matter expert during regulatory inspections and audits
• Support and advise the Senior Director of Statistical Programming on inspection strategy and readiness
• Prepare programming teams and leadership for inspection-related questions and interactions
• Collaborate cross-functionally with QA, Regulatory Affairs, Clinical, Biometrics, and other stakeholders
• Review and assess programming documentation, processes, and outputs for inspection readiness
• Respond to inspection questions related to programming, data traceability, and submission standards
• Provide as-needed statistical programming support, review, or troubleshooting (secondary responsibility)
• Communicate clearly and confidently with senior management and regulatory inspectors

Required Qualifications

• 10-15+ years of industry experience and prior experience acting as a primary or key inspection readiness lead
• Extensive experience supporting EMA and/or BLA inspections and audits
• Senior-level statistical programming background (e.g., former Lead / Managing Programmer or equivalent)
• Strong knowledge of CDISC standards (SDTM/ADaM) and submission programming
• Demonstrated experience interfacing with management during inspections or audits
• Proven ability to work cross-functionally beyond biometrics
• Excellent verbal and written communication skills
• Comfortable operating in a consulting/advisory capacity, leading without formal authority

Preferred Qualifications

• Experience supporting both US FDA and EMA inspections
• Bay Area local or able to travel onsite as needed