Sr. Statistical Programmer - Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Statistical Programmer - Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs. The ideal candidate is a detail-oriented statistical programmer with a strong interest in clinical data analysis, regulatory processes (such as PMA or 510(k) submissions), and continual learning in a regulated environment.

Essential Job Functions

• Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) that support clinical trial reporting, regulatory submissions, and publications.

• Implement and maintain standardized programming templates, macros, and tools to ensure consistency, efficiency, and compliance across clinical studies.

• Contribute to the creation and review of programming specifications for SDTM and ADaM like datasets based on CDISC standards and internal guidelines.

• Assist in programming support for data cleaning, interim analyses, medical review, and final study reports.

• Collaborate with statisticians, data managers, clinical team members, and external vendors to ensure timely and high-quality deliverables.

• Review Statistical Analysis Plans (SAP) with biostatisticians to anticipate any complications or complexities for programming activities.

• Perform quality control (QC) and validation of internally and externally developed datasets and outputs, adhering to company SOPs and programming best practices.

• Integrate data across multiple studies for pooled analyses, submission packages, or visual summaries to support regulatory filings or internal strategy.

• Document all programming activities clearly and thoroughly, supporting reproducibility and regulatory compliance in a validated programming environment.

• Use version control systems and structured documentation to support audit readiness and collaborative programming practices.

• Contribute to posters, presentations, or ad hoc analyses, including visual data summaries using SAS graphics or other data visualization tools.

• Other duties as required

Requirements

• Bachelor’s degre