[Hiring] Associate Director, Statistical Programming @Cabaletta Bio

Role Description

Reporting to the Senior Director (Head) of Statistical Programming, the Director, Statistical Programming, is responsible for overseeing all statistical programming deliverables in adherence to ICH/GCP/CDISC guidance. The individual works closely with the Senior Director, Statistical Programming to create and implement statistical programming policies and procedures, provide oversight on analysis of clinical trials, and support internal analysis needs.

Responsibilities

• Responsible for the statistical programming activities for CSR, publications, presentations, various reports for health authority submissions, clinical data review, and ad-hoc analysis either internally or through CRO partners.
• Work with the biostatistician to build and maintain secure statistical computing and programming infrastructure.
• Interact with members of project teams, biostatistician, and data management personnel to establish project timelines and perform statistical analyses.
• Manage and provide oversight of Statistical Programming FTEs, contractors, and CROs to ensure high-quality statistical analysis deliverables (datasets, TLFs, etc.) within timeline and budget.
• Author or Review SDTM and ADaM specifications to ensure compliance to CDISC standards.
• Review key clinical study or program documents.
• Develop SAS code, manage macro library and templates for efficiently preparing, processing, analyzing clinical data and validating analysis results.
• Author and/or review statistical analysis related SOPs.
• Additional duties and responsibilities as required.

Qualifications

• 8 years of statistical programming industry experience.
• Bachelor’s or master’s degree in any quantitative or computing field.
• Solid understanding of industry standards applicable to clinical study data and regulatory reporting requirements including eCTD and CDISC implementation.
• Expert level SAS programming (Base, Macro, STAT, GRAPH, SQL) with experience delivering complex programming assignments, macros, and analyses.
• Experience managing CROs for outsourced statistical programming activities.
• Expertise in the requirements and technology to support electronic submissions.
• Thorough knowledge of SDTM/ADaM specifications and programming.
• Strong analytical and communication skills.
• Strong team orientation and passion for continuous self-development.

Preferred Qualifications

• Experience in rare disease studies preferred.
• Extensive experience leading early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures.
• Experience with BLA, NDA/sNDA submissions to FDA/EMA strongly preferred.
• Experience in industry or in a startup industrial setting is preferred.

Benefits

• Competitive benefits.
• PTO.
• Stock option plans.

Company Description

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.