Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus and myositis are now recruiting.

Join Our Crew

Associate Director/Director Statistical Programming (Remote)

About the Position

Join our growing clinical team as the first Associate Director/Director, Statistical Programming. Reporting to the Senior Director (Head) of Biostatistics, you will be responsible for all statistical programming deliverables in adherence to ICH/GCP guidance. You will work closely with the Senior Director, Biostatistics to create and implement statistical programming policies and procedures.

Responsibilities Include

  • You will be 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

  • Bachelor’s or master’s degree in any quantitative or computing field with at least 10 years statistical programming experience
  • 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 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 managing CROs for outsourced statistical programming activities
  • Expertise in the requirements and technology to support electronic submissions
  • Experience with BLA, NDA/sNDA submissions to FDA/EMA strongly preferred
  • Thorough knowledge of SDTM/ADaM specifications and programming
  • Strong analytical and communication skills
  • Strong team orientation and passion for continuous self-development.
  • Experience in industry or in a startup industrial setting is preferred.


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How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

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

Equal Opportunity Employer

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.