Manager, Statistical Programming

Role Description

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

The Manager of Statistical Programming provides technical and operational leadership for statistical programming activities supporting Circulatory Restoration’s 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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• Vacation – 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• 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