Lead Principal Statistical Programmer - Submissions Expert

Jazz Pharmaceuticals, Inc.; Philadelphia (Philadelphia County); On-site; USD 138,000 - 208,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Principal Statistical Programmer to lead programming activities for neuroscience or oncology trials. You will deliver CDISC-compliant datasets, TFLs, ISS/ISE, and submission-ready materials while guiding junior programmers and CRO partners.

The role requires expert SAS, CDISC, and regulatory experience, with collaboration across biostatistics, data management, and regulatory operations to ensure timely, high-quality deliverables.

Qualifications

• Mastery of SAS and data manipulation in a validated clinical environment.
• CDISC SDTM and ADaM knowledge with define.xml experience.
• Experience supporting NDA/BLA/MAA submissions.
• Strong analytical and problem-solving abilities in data workflows.

Responsibilities

• Lead programming across complex Phase I–IV trials or multi-study programs, from startup to CSR and filing.
• Author and review SAPs, datasets, and TFLs in collaboration with statisticians and scientists.
• Oversee CRO deliverables and ensure alignment with Jazz standards and regulatory guidelines.
• Mentor junior programmers and contribute to automation and standards development.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

R/Python basics

GxP compliance

Cross-functional collaboration

Data analysis

Education

Statistics/Biostatistics degree

Tools

Pinnacle 21

Job description

Jazz Pharmaceuticals, Inc. is seeking a Principal Statistical Programmer to lead programming activities for neuroscience or oncology trials. You will deliver CDISC-compliant datasets, TFLs, ISS/ISE, and submission-ready materials while guiding junior programmers and CRO partners.

The role requires expert SAS, CDISC, and regulatory experience, with collaboration across biostatistics, data management, and regulatory operations to ensure timely, high-quality deliverables.