Manager, Statistical Programming - Shockwave Medical

Johnson & Johnson • Santa Clara, CA

6d • Remote

About The Position

Johnson & Johnson is hiring for a Manager, Statistical Programming – Shockwave Medical to join their team. This role is fully remote within the United States. The company is focused on healthcare innovation, aiming to prevent, treat, and cure complex diseases with smarter, less invasive solutions. They are pioneering the development and commercialization of Intravascular Lithotripsy (IVL) for treating complex calcified cardiovascular disease, aiming to establish a new standard of care.

The Manager of Statistical Programming provides technical and operational leadership for statistical programming activities supporting clinical studies, regulatory submissions, publications, and post-market evidence generation for Circulatory Restoration. 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.

Requirements

• Bachelor’s 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.

Nice To Haves

• Advanced degree
• Direct people management experience
• Experience with R, Python, data visualization, automation, or modern analytics platforms

Responsibilities

• 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.

Benefits

• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Long-term incentive program
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year (varies by state)
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager