Associate Director, Statistical Programming

MBX Biosciences • Burlington, MA

1d

About The Position

MBX is seeking an Associate Director, Statistical Programming to lead and contribute to the statistical programming and analysis of clinical trial data. This role is integral to the design, execution, and interpretation of analyses for clinical trials and related research activities. The Associate Director will ensure the quality and accuracy of statistical deliverables, oversee external vendor performance, and contribute to internal process improvements, including maintaining SAS macros and safety databases.

Requirements

• 8+ years of statistical programming experience in the biotech or pharmaceutical industry, with a preference for expertise in endocrine and metabolic disorders.
• Advanced degree (PhD, MS, BS, etc.) in life sciences, biostatistics, mathematics, computer science, or a related field preferred.
• Proficient in SAS programming (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) with a solid understanding of database systems.
• Extensive experience with CDISC standards (SDTM, ADaM) and electronic submissions (eSub).
• Proven ability to lead programming activities and provide oversight of CRO deliverables.
• Strong analytical, organizational, and communication skills, with a keen eye for detail and the ability to manage multiple priorities in a dynamic, fast-paced environment.
• Demonstrated leadership in cross-functional teams, experience with global submissions, and knowledge of safety database management.

Responsibilities

• Oversee and execute statistical programming deliverables for planned analyses, including study monitoring, clinical study reports, data integrations, and responses to regulatory queries across multiple compounds and studies.
• Lead global submission activities, acting as a programming functional and technical expert to support submission strategy planning and regulatory communications.
• Manage CROs and contractors to ensure compliance, high-quality deliverables, adherence to timelines, and budget alignment.
• Develop and validate statistical programs to produce outputs for integrated scientific reports of clinical trial results, ensuring adherence to protocols and Statistical Analysis Plans (SAPs).
• Maintain and enhance the internal SAS macro library and safety database.
• Provide statistical input for SAPs, publications, scientific presentations, and promotional materials.
• Review Case Report Forms (CRFs), CRF annotations, SAPs, Table, Listing, and Figure (TLF) shells, and TLF outputs.
• Serve as an indication lead for statistical programming within study teams, effectively communicating statistical and programming issues to development teams.
• Create and review derived dataset specifications and the related analysis datasets.
• Other responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level