Associate Director, Statistical Programming

Position Title:  Associate Director, Statistical Programming

Location: Remote

Reports to: Gonzalo Vega

Department: Statistical Programming

Date Approved: 9/1/2026

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. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

About the Position:

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.

Required Qualifications:

(What to consider)

• 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:

(What to consider)

• 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.

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.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

#LI-REMOTE