Senior Statistical Programming Lead – Global Submissions (Hybrid)

MBX Biosciences, Inc.; Burlington (MA); Hybrid; USD 140,000 - 210,000; Full time

Job summary

MBX Biosciences, Inc. in Massachusetts is seeking an Associate Director, Statistical Programming to lead statistical programming for clinical trials, ensure the quality of deliverables, and oversee external vendors.

The role supports regulatory submissions and internal process improvements across multiple compounds. You will manage global submission activities, maintain SAS macros and workflows, contribute to SAPs and publications, and mentor cross-functional teams in a fast-paced,

Qualifications

• 8+ years of statistical programming experience in biotech or pharmaceutical industry.
• Advanced degree (PhD, MS, or equivalent) in life sciences, biostatistics, mathematics, computer science, or a related field.
• Proficient in SAS programming (Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) with a solid database understanding.
• Experience with R and Python for advanced data visualization and analysis.
• Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and electronic submissions (eSub) under eCTD.
• Proven ability to lead programming activities and oversee CRO deliverables.
• Strong analytical, organizational, and communication skills; detail-oriented; capable of managing multiple priorities.
• Demonstrated leadership in cross-functional teams, global submissions, and database management.

Responsibilities

• Oversee and execute statistical programming deliverables for planned analyses and regulatory responses across multiple compounds and studies.
• Lead global submission activities, acting as a programming expert to support strategy planning and regulatory communications.
• Manage CROs and contractors to ensure high-quality deliverables, timelines, and budget adherence.
• Develop and validate reproducible programs to produce outputs for integrated trial reports, adhering to SAPs and regulatory conventions.
• Maintain and enhance the internal SAS macro library and database.
• Provide programming input for SAPs, publications, scientific presentations, regulatory submissions, and promotional materials.
• Review CRFs, SAPs, TLFs, and dataset specifications (SDTM/ADaM).
• Serve as a study-team lead for statistical programming, communicating issues clearly to cross-functional teams.
• Contribute to programming standards, macros, SOPs, and process improvements within Biometrics.
• Other responsibilities as assigned.

Skills

SAS programming

R & Python

CDISC SDTM/ADaM

eCTD submissions

CRO oversight

Data management

Leadership

Regulatory experience

Education

PhD or MSc in life sciences/biostatistics/related field

Tools

SAS

R

Python

Job description

MBX Biosciences, Inc. in Massachusetts is seeking an Associate Director, Statistical Programming to lead statistical programming for clinical trials, ensure the quality of deliverables, and oversee external vendors.

The role supports regulatory submissions and internal process improvements across multiple compounds. You will manage global submission activities, maintain SAS macros and workflows, contribute to SAPs and publications, and mentor cross-functional teams in a fast-paced,