Associate Director, Statistical Programming

About the role

Cabaletta Bio is recruiting an Associate Director, Statistical Programming for its RESET clinical trials with rese-cel (an investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis and pemphigus vulgaris. The role reports to the Senior Director (Head) of Statistical Programming and oversees all statistical programming deliverables in line with ICH/GCP/CDISC guidance, working closely with the Senior Director to set policies and procedures, oversee trial analyses and support internal analysis needs. The position is remote.

Key responsibilities

• Handle statistical programming for CSR, publications, presentations, health authority submission reports, clinical data review and ad-hoc analysis, internally or through CRO partners.
• Work with the biostatistician to build and maintain a secure statistical computing and programming infrastructure.
• Collaborate with project teams, biostatisticians and data management to set timelines and run statistical analyses.
• Manage and oversee Statistical Programming FTEs, contractors and CROs to deliver high-quality datasets, TLFs and other deliverables on time and within budget.
• Author or review SDTM and ADaM specifications and review key clinical study or program documents.
• Develop SAS code, manage the macro library and templates, and author or review statistical analysis SOPs.

Required profile

• 8 years of statistical programming industry experience.
• Bachelor's or master's degree in a quantitative or computing field.
• Solid understanding of industry standards for clinical study data and regulatory reporting, including eCTD and CDISC.
• Experience managing CROs for outsourced statistical programming.
• Expertise supporting electronic submissions.
• Strong analytical and communication skills, team orientation and passion for continuous development.

Required skills

• Expert-level SAS programming (Base, Macro, STAT, GRAPH, SQL).
• Thorough knowledge of SDTM/ADaM specifications and programming.
• Preferred: rare disease studies, early and late-phase study leadership, and BLA/NDA/sNDA submissions to FDA/EMA.

What we offer

• Health and retirement benefits.
• PTO.
• Stock option plans.