Remote Associate Director, Statistical Programming Lead

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); Remote; USD 140.000 - 210.000; Vollzeit

Benefits dieser Stelle

Health and retirement benefits

PTO

Stock option plans

Zusammenfassung

Cabaletta Bio is seeking an Associate Director of Statistical Programming, fully remote in the United States. The role reports to the Senior Director and oversees all statistical programming deliverables in line with ICH/GCP/CDISC guidance, including CSR, publications, and health authority submissions.

You will collaborate with the biostatistics team to build secure infrastructure, manage CROs, and ensure high-quality analyses and compliant SDTM/ADaM specifications across studies.

Qualifikationen

• 8 years of statistical programming industry experience.
• Bachelor’s or Master’s degree in any quantitative or computing field.
• Strong knowledge of CDISC, eCTD, and regulatory reporting requirements.
• Expert SAS programming (Base, Macro, STAT, GRAPH, SQL).
• Experience managing CROs for outsourced statistical programming activities.
• Expertise in SDTM/ADaM specifications and programming.
• Strong analytical and communication skills.
• Team orientation and passion for continuous self-development.

Aufgaben

• 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 project teams, biostatistician, and data management to establish timelines and perform analyses.
• Manage and provide oversight of Statistical Programming FTEs, contractors, and CROs to ensure high-quality deliverables within timeline and budget.
• Author or Review SDTM and ADaM specifications to ensure CDISC compliance.
• Review key clinical study or program documents.
• Develop SAS code, manage macro library and templates for data processing and validation.
• Author and/or review statistical analysis related SOPs.
• Additional duties as required.

Kenntnisse

SAS programming

Leadership

Communication

Team collaboration

CDISC SDTM/ADaM

Regulatory submissions

Project management

GCP/ICH knowledge

Ausbildung

Bachelor’s or Master’s in quantitative field

Tools

SAS

SAS Macro

Jobbeschreibung

Cabaletta Bio is seeking an Associate Director of Statistical Programming, fully remote in the United States. The role reports to the Senior Director and oversees all statistical programming deliverables in line with ICH/GCP/CDISC guidance, including CSR, publications, and health authority submissions.

You will collaborate with the biostatistics team to build secure infrastructure, manage CROs, and ensure high-quality analyses and compliant SDTM/ADaM specifications across studies.