Lead Statistical Programming - Biotech Trials

MBX Biosciences, Inc.; Burlington (MA); Hybride; USD 180 000 - 240 000; Plein temps

Résumé du poste

MBX Biosciences, Inc. is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and analysis of clinical trial data. This role ensures quality and accuracy of deliverables, oversees vendor performance, and drives process improvements within Biometrics.

You will maintain and expand SAS macros, implement SDTM/ADaM standards, and support regulatory submissions (FDA/EMA). Travel is periodic; hybrid schedule in a fast-paced, mission-driven team.

Qualifications

• 8+ years of statistical programming experience in biotech/pharma.
• Advanced degree in life sciences, biostatistics, mathematics, or related field preferred.
• Proficiency in SAS programming with macros and ODS; experience with database systems.
• Experience with R and Python for data visualization and analysis.
• CDISC standards (SDTM/ADaM) and eSub/eCTD submissions experience.
• Strong leadership and cross-functional collaboration skills.

Responsabilités

• Oversee statistical programming deliverables across multiple studies.
• Lead global submission activities and support regulatory communications.
• Manage CROs and contractors to ensure quality and timelines.
• Develop and validate reproducible programs for SAPs and trial reports.
• Maintain SAS macro library and data repositories.
• Provide input for SAPs, publications, and regulatory submissions.
• Review SDTM/ADaM datasets and TLF outputs in study teams.
• Lead statistical programming within study teams and drive standards.

Connaissances

SAS programming

R

Python

CDISC SDTM/ADaM

Leadership

Regulatory submissions

Formation

PhD or MS in life sciences/biostatistics/related field

Outils

Base SAS

SAS/STAT

SAS/Graph

SAS macros

Description du poste

MBX Biosciences, Inc. is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and analysis of clinical trial data. This role ensures quality and accuracy of deliverables, oversees vendor performance, and drives process improvements within Biometrics.

You will maintain and expand SAS macros, implement SDTM/ADaM standards, and support regulatory submissions (FDA/EMA). Travel is periodic; hybrid schedule in a fast-paced, mission-driven team.