Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases, including SLE/lupus nephritis and myositis and which uses a CD-19 binder that has an encouraging clinical tolerability profile. The second strategy is Cabaletta Bio’s proprietary CAART, or chimeric autoantibody receptor T cells, strategy, which is designed to cause antigen-specific B cell depletion of well-defined, disease-causing B cells. Our lead product candidate developed using the CAART strategy is being evaluated in a clinical trial for patients with mucosal pemphigus vulgaris (mPV) and our second product candidate is expected to initiate a clinical trial later this year in muscle-specific tyrosine kinase (MuSK) myasthenia gravis. Cabaletta Bio’s headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and Twitter.

 

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

 

The Senior Director of Biostatistics is responsible for overseeing the statistical aspects of clinical research programs for the company. The Senior Director of Biostatistics must have a deep understanding of statistical methodologies and their application to clinical trials, as well as a strong business acumen to effectively manage resources, timelines, and budgets. The role requires strong interpersonal skills and the ability to effectively communicate with both technical and non-technical stakeholders.

Responsibilities:

• Build and lead the Biostatistics and Data Management functions within the organization, managing a team of statisticians, programmers, and data managers to ensure the timely and accurate delivery of statistical outputs for clinical studies.
• Develop statistical analysis plans and oversee the implementation of statistical methodologies for clinical studies, ensuring their compliance with regulatory guidelines and data management standards for regulatory inspections and/or submissions.
• Provide strategic input to study design, protocol development, and clinical development plans to ensure optimal study designs and efficient use of resources.
• Collaborate with cross-functional teams including clinical development, clinical operations, regulatory affairs, pharmacovigilance, and medical affairs to ensure the successful execution of clinical trials.
• Ensure that all statistical analyses are of high quality and are appropriately documented, and that the conclusions drawn from the analyses are supported by the data.
• Provide statistical support for regulatory submissions, including authoring and reviewing statistical sections of regulatory documents.
• Ensure compliance with applicable regulatory guidelines, industry standards, and company policies.
• Manage departmental resources, including budget, personnel, vendor oversight, and technology infrastructure, to ensure the delivery of high-quality statistical input.
• Develop and maintain relationships with key external stakeholders, including regulatory agencies, academic institutions, contract research organizations, vendors and other industry organizations.

Qualifications:

• PhD or master’s degree in Biostatistics or related field and 10+ years related work experience.
• At least 7 years of experience in the pharmaceutical/biotech industry or clinical research organization in the design/analysis of early- and registration-stage programs
• Proven track record of successful leadership in Biostatistics, with experience managing teams of statisticians and data managers.
• Strong knowledge of statistical methodologies and their application to clinical research.
• Excellent communication, leadership, and interpersonal skills.
• Demonstrated ability to work effectively with cross-functional teams.
• Track record of successful regulatory submissions, including deep knowledge of regulatory guidelines and industry standards.
• Strong business acumen, with experience managing budgets and resources.
• Strong team orientation and passion for continuous self-development.
• Excellent leadership and organizational skills, highly collaborative and supportive, attention to detail, time management, and flexible attitude with respect to work assignments
• Embraces new learning and demonstrates strong ability to communicate and interact in a team environment.
• Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Strong team orientation and passion for continuous self-development.
• Experience in industry or in ap 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.