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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 Principal Biostatistician – Shockwave Medica l to join our team located in Santa Clara, CA.

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 Principal Biostatistician will use statistical expertise in study design and analysis of data to support the generation of evidence for regulatory and commercial needs. Responsibilities include the development of Statistical Analysis Plans, including statistical methodology, definition of derived variables, data-handling rules, mockups and ultimately analysis of study data in support of business needs. This work is accomplished with limited supervision and requires a motivated self-starter who can work independently.

Essential Job Functions

• Participate in the design and execution of global studies for regulatory submissions, reimbursement, and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.

• Statistical programming of deliverables for regulatory submissions, including specification and delivery of integrated databases, outputs, and response to regulatory questions.

• Lead analysis for publications or podium presentations.

• Develop SAS macros, templates and utilities for data reporting and visualization.

• Write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets.

• Proactively seek out and follow best practices in programming documentation.

• Lead the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams.

• Regularly communicates study status to senior management and represents the organization to key customers.

• Other duties as assigned.

Requirements

• B.S. degree in statistics, computer science, mathematics or related areas and 10+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry or a master’s degree in Biostatistics or Epidemiology and 8+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry

• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials

• Proficiency in SAS and SAS macros that includes the use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis required

• Experience with analysis of medical device trials for PMA or 510(k) preferred

• Excellent critical thinking skills

• Ability to work effectively on cross-functional teams

• Effective communication skills with all levels of management and organizations

• Can operate within a team and independently, with adaptability to changing requirements

Pay Transparency:

• The anticipated salary range for this position is $121,000 - $194,350

• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$121,000 - $194,350

Additional Description for Pay Transparency: