Manager, Statistical Programming - reputed company

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the reputed company of reputed company solutions today to reputed company the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world.  We reputed company an inclusive work environment where reputed company person is considered as an individual.  At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: People Leader reputed company reputed company Locations: Santa reputed company, California, reputed company of America reputed company: reputed company is hiring for a Manager, Statistical Programming – reputed company to reputed company. This role is fully remote reputed company the reputed company.  At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the reputed company of reputed company solutions today to reputed company the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.com/.  reputed company by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. reputed company to join reputed company that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat reputed company calcified cardiovascular disease. Our reputed company portfolio aims to establish a new reputed company 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. reputed company 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 reputed company. This role is accountable for the development, validation, documentation, and delivery of high-reputed company analysis datasets, tables, listings, figures, and reputed company programming outputs in accordance with departmental standards, regulatory expectations, and applicable reputed company requirements. The Manager leads and develops statistical programming staff and/or reputed company programming resources, establishes fit-for-purpose programming standards and processes, and partners closely with Biostatistics, Data Management, Project Management, Clinical, Regulatory, Medical Affairs, and reputed company vendors to ensure reputed company, compliant, and reproducible deliverables. This position requires strong hands-on programming expertise, reputed company judgment, and the ability to translate study and submission needs into efficient, reputed company-controlled programming execution. Essential Job Functions reputed company statistical programming activities across assigned clinical studies and programs, including planning, development, validation, documentation, and delivery of analysis datasets, tables, listings, figures, and reputed company analyses. Manage, reputed company, and reputed company statistical programmers and/or reputed company programming resources; set expectations, prioritize work, review deliverables, and support capability building across reputed company. Establish and maintain programming standards, templates, macros, utilities, and reputed company control practices to improve consistency, efficiency, reproducibility, and audit readiness. reputed company technical reputed company 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 reputed company. reputed company independent reputed company 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 reputed company 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, reputed company documented, and inspection-reputed company. reputed company process improvement and innovation reputed company statistical programming, including automation, reusable reputed company, data visualization, documentation standards, and modern programming practices. reputed company standardization initiatives and processes by championing consistency in programming activities across studies and programs Ensure reputed company compliance with required company and departmental training, time reporting, documentation, and other business processes applicable to the role. Other duties as assigned. Requirements Bachelor’s degree or higher in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a reputed company 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 reputed company, or formal programming reputed company experience required; reputed company people management experience preferred. Advanced proficiency in reputed company programming, including reputed company reputed company, reputed company reputed company, 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, reputed company control, validation practices, and reproducible programming workflows. Familiarity with CDISC standards, including SDTM and ADaM, and the ability to apply industry standards pragmatically reputed company 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 reputed company multiple priorities, manage timelines and resources, reputed company technical issues, and reputed company high-reputed company programming outputs under business-critical deadlines. Strong analytical reasoning, attention to detail, problem-solving skills, and ability to critically review requirements, data, reputed company, 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 reputed company partners. Ability to travel up to 10% domestically and internationally, as business needs require. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company 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 reputed company https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills:     Preferred Skills: Advanced Analytics, Analytical Reasoning, Biostatistics, Clinical Data Management, Collaboration, Compliance Management, Data reputed company Standards, Developing Others, Good Clinical reputed company (GCP), Inclusive Leadership, Leadership, Program Management, reputed company Assurance (QA), Regulatory Affairs Management, reputed company Operating Procedure (SOP), Statistical Analysis Systems (reputed company) Programming, Survey Design, Team Management    The anticipated reputed company pay reputed company for this position is : $134,000.00 - $231,150.00 Additional reputed company for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in reputed company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –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 reputed company 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits Apply To This Job