Remote Principal Statistical Programmer & CDISC Lead

Jazz Pharmaceuticals, Inc.; Cambridge; A distancia; GBP 90.000 - 120.000; Jornada completa

Descripción de la vacante

Jazz Pharmaceuticals, Inc. is seeking a Principal Statistical Programmer to lead programming across Neuroscience or Oncology trials. You will deliver CDISC SDTM/ADaM datasets, TFLs, ISS/ISE, and submission-ready documentation, while mentoring junior programmers and coordinating CRO work.

Responsibilities include authoring SAPs, specs, and timelines; validating CDISC implementations; producing tables/listings for CSRs and filings; and guiding automation of workflows.

Formación

• Bachelor’s, Master’s, or Ph.D. in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline.
• Minimum of 8 years of statistical programming experience in pharma/biotech/CRO.
• Experience as primary study/program lead programmer for multiple clinical studies.
• Direct experience supporting major regulatory filings (NDA/BLA/MAA) preferred.

Responsabilidades

• Lead programming across complex Phase I–IV trials or multi-study programs.
• Author, review, and finalize SAPs, dataset specifications, and TFL shells with biostatisticians.
• Direct study-level programming timelines, resources, and risk mitigation.
• Architect and validate CDISC SDTM/ADaM datasets per guidelines.
• Create, validate, and troubleshoot tables, figures, listings for CSRs, SDRG/ADRG, and ISS/ISE.
• Lead submission datasets and documentation packaging (Define.xml, SDRG/ADRG, Pinnacle 21) per regulatory standards.
• Prepare ISS/ISE for global regulatory filings (NDA/BLA/MAA).
• Mentor junior programmers and oversee CRO deliverables.

Conocimientos

SAS

R/Python

CDISC SDTM/ADaM

Define.xml

Pinnacle 21

Regulatory submissions

GxP Compliance

Educación

Bachelor/Master/PhD in statistics or related

Herramientas

SAS

R

Python

Descripción del empleo

Jazz Pharmaceuticals, Inc. is seeking a Principal Statistical Programmer to lead programming across Neuroscience or Oncology trials. You will deliver CDISC SDTM/ADaM datasets, TFLs, ISS/ISE, and submission-ready documentation, while mentoring junior programmers and coordinating CRO work.

Responsibilities include authoring SAPs, specs, and timelines; validating CDISC implementations; producing tables/listings for CSRs and filings; and guiding automation of workflows.