Lead Statistical Programmer – Regulatory Submissions Expert

Jazz Pharmaceuticals, Inc.; Palo Alto (CA); On-site; USD 138,000 - 208,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401k retirement savings plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals, Inc. seeks a Principal Statistical Programmer to lead programming for complex clinical programs in neuroscience or oncology. You will oversee CDISC-compliant datasets, TFLs, ISS/ISE, and submission deliverables, while mentoring junior staff and guiding CRO partners.

You will collaborate with biostatisticians and scientists to shape SAPs, ensure regulatory readiness, and drive automation across the programming department.

Qualifications

• Mastery of SAS (Base, Macro, ODS) in validated environments.
• CDISC SDTM/ADaM, Define.xml, and Pinnacle 21 proficiency.
• Experience supporting NDA/BLA/MAA submissions.
• Strong data algorithms, data workflow optimization.
• Excellent cross-functional collaboration skills.

Responsibilities

• Lead programming across complex trials from startup to filing.
• Author SAPs, datasets specs, and TFLs with statisticians.
• Ensure CDISC compliance and regulatory readiness.
• Mentor junior programmers and oversee CRO deliverables.
• Develop macros, automation, and reusable workflows.

Skills

Leadership

Cross-functional

Regulatory coordination

Problem solving

Education

Bachelor's, Master's, or Ph.D. in Statistics / Biostatistics / CS / Math

8+ years in statistical programming (pharma/CRO)

Tools

SAS

R

Python

CDISC SDTM/ADaM

Pinnacle 21

Job description

Jazz Pharmaceuticals, Inc. seeks a Principal Statistical Programmer to lead programming for complex clinical programs in neuroscience or oncology. You will oversee CDISC-compliant datasets, TFLs, ISS/ISE, and submission deliverables, while mentoring junior staff and guiding CRO partners.

You will collaborate with biostatisticians and scientists to shape SAPs, ensure regulatory readiness, and drive automation across the programming department.