Manager, Statistical Programming Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Johnson & Johnson is hiring for a Manager Statistical Programming Shockwave Medical to join our team. This role is fully remote within the United States.

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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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 Manager of Statistical Programming provides technical and operational leadership for statistical programming activities supporting Circulatory Restorations clinical studies regulatory submissions publications and post-market evidence generation. This role is accountable for the development validation documentation and delivery of high-quality analysis datasets tables listings figures and related programming outputs in accordance with departmental standards regulatory expectations and applicable quality requirements.

The Manager leads and develops statistical programming staff and/or external programming resources establishes fit-for-purpose programming standards and processes and partners closely with Biostatistics Data Management Project Management Clinical Regulatory Medical Affairs and external vendors to ensure timely compliant and reproducible deliverables. This position requires strong hands-on programming expertise sound judgment and the ability to translate study and submission needs into efficient well-controlled programming execution.

Essential Job Functions

• Lead statistical programming activities across assigned clinical studies and programs including planning development validation documentation and delivery of analysis datasets tables listings figures and ad hoc analyses.
• Manage coach and develop statistical programmers and/or external programming resources; set expectations prioritize work review deliverables and support capability building across the team.
• Establish and maintain programming standards templates macros utilities and quality control practices to improve consistency efficiency reproducibility and audit readiness.
• Provide technical oversight for the creation and review of programming specifications for analysis datasets and reporting outputs including SDTM- and ADaM-like data structures where applicable.
• Review statistical analysis plans study protocols data structures and reporting requirements to identify programming risks data gaps operational dependencies and opportunities to improve execution quality.
• Oversee independent quality control and validation of internally and externally developed programs datasets and outputs in alignment with company SOPs GCP GxP expectations and programming best practices.
• Partner with Biostatistics Data Management Clinical Operations Regulatory Medical Affairs and vendors to align programming deliverables with study milestones regulatory submissions publications and business priorities.
• Support regulatory submissions and responses to health authority questions by ensuring programming outputs are accurate traceable well documented and inspection-ready.
• Drive process improvement and innovation within statistical programming including automation reusable code data visualization documentation standards and modern programming practices.
• Drive standardization initiatives and processes by championing consistency in programming activities across studies and programs
• Ensure continued compliance with required company and departmental training time reporting documentation and other business processes applicable to the role.
• Other duties as assigned.

Requirements

• Bachelors degree or higher in Statistics Biostatistics Mathematics Computer Science Life Sciences or a related discipline; advanced degree preferred.
• Typically 10 years of statistical programming experience in the medical device pharmaceutical biotechnology or clinical research industry including experience supporting clinical studies regulatory submissions clinical study reports and/or publications.
• Prior people management project leadership vendor oversight or formal programming lead experience required; direct people management experience preferred.
• Advanced proficiency in SAS programming including Base SAS SAS Macro SQL and statistical procedures; experience with R Python data visualization automation or modern analytics platforms is preferred.
• Strong working knowledge of clinical trial data structures analysis datasets tables listings figures programming specifications quality control validation practices and reproducible programming workflows.
• Familiarity with CDISC standards including SDTM and ADaM and the ability to apply industry standards pragmatically within medical device or clinical research settings.
• Knowledge of GCP GxP FDA and international regulatory expectations and documentation practices supporting audit readiness and regulatory compliance.
• Demonstrated ability to lead multiple priorities manage timelines and resources resolve technical issues and deliver high-quality programming outputs under business-critical deadlines.
• Strong analytical reasoning attention to detail problem-solving skills and ability to critically review requirements data code and outputs to identify risks and propose effective solutions.
• Excellent communication collaboration and stakeholder management skills with the ability to work effectively across Biostatistics Data Management Clinical Regulatory Medical Affairs and external partners.
• Ability to travel up to 10% domestically and internationally as business needs require.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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Manager