Associate Director, Statistical Programming

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health and retirement benefits

PTO

Stock option plans

Job summary

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.

Qualifications

• 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.

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 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.

Skills

SAS programming

Leadership

Communication

Team collaboration

CDISC SDTM/ADaM

Regulatory submissions

Project management

GCP/ICH knowledge

Education

Bachelor’s or Master’s in quantitative field

Tools

SAS

SAS Macro

Job description

Associate Director, Statistical Programming

Remote

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 Include

• 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 is 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 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.