Associate Director, Statistical Programming
MBX Biosciences, Inc.
August 17, 2026
Remote friendly (Burlington, MA)
United States
Clinical Research and Development
Position Summary
MBX is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and analysis of clinical trial data.
What You’ll Do
- 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.
What You Bring
- 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.
Travel & In Office Presence
- Periodic travel and hybrid work schedule based on business needs/office practices.
MBX is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and analysis of clinical trial data.
What You’ll Do
- 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.
What You Bring
- 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.
Travel & In Office Presence
- Periodic travel and hybrid work schedule based on business needs/office practices.