Associate Director, Statistical Programming

Position Summary

MBX is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and analysis of clinical trial data.

• Oversee and execute statistical programming deliverables for planned analyses (study monitoring, data reviews, clinical study reports, data integrations, regulatory query responses) across compounds and studies.
• Lead global submission activities as a programming functional/technical expert; ensure deliverables meet timelines, quality, and regulatory expectations (ICH/FDA/EMA).
• Manage CROs/contractors to ensure compliant, high-quality deliverables within timeline and budget.
• Develop and validate reproducible, well-documented statistical programs for integrated scientific reports, aligned to protocols and Statistical Analysis Plans (SAPs) and regulatory conventions.
• Maintain and enhance the internal SAS macro library and database.
• Provide input to SAPs, publications, scientific presentations, regulatory submissions, and promotional materials.
• Review CRFs/CRF annotations, SAPs, TLF shells and outputs, and dataset specifications (SDTM/ADaM).
• Lead statistical programming within study teams; communicate statistical/programming issues to development teams.
• Contribute to programming standards, macros, SOPs, and process improvements.
• Other responsibilities as assigned.

• 8+ years statistical programming experience in biotech/pharma (preferred: endocrine/metabolic disorders).
• Advanced degree (PhD/MS/etc.) preferred.
• Proficient in SAS (Base SAS, SAS/Stat, SAS/Graph, macros, ODS) and solid understanding of database systems.
• R and Python experience preferred.
• CDISC experience (SDTM, ADaM, define.xml) and eCTD/eSub submissions.
• Ability to lead programming and oversee CRO deliverables.
• Strong analytical, organizational, communication skills; manage multiple priorities.

• Periodic travel and hybrid work schedule based on business needs/office practices.