Sr. Statistical Programmer - Shockwave Medical
Sr. Statistical Programmer - Shockwave Medical
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 103000 - 165600
1 Vacancy
Job Description
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
Job Function:
Data Analytics & Computational SciencesJob Sub Function:
BiostatisticsJob Category:
Scientific/TechnologyAll Job Posting Locations:
Santa Clara California United States of AmericaJob Description:
Johnson & Johnson is hiring for a Sr. Statistical Programmer - Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US.
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 Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g. SDTM ADaM) across clinical programs. The ideal candidate is a detail-oriented statistical programmer with a strong interest in clinical data analysis regulatory processes (such as PMA or 510(k) submissions) and continual learning in a regulated environment.
Essential Job Functions
Develop and validate SAS programs to generate analysis datasets tables listings and figures (TLFs) that support clinical trial reporting regulatory submissions and publications.
Implement and maintain standardized programming templates macros and tools to ensure consistency efficiency and compliance across clinical studies.
Contribute to the creation and review of programming specifications for SDTM and ADaM like datasets based on CDISC standards and internal guidelines.
Assist in programming support for data cleaning interim analyses medical review and final study reports.
Collaborate with statisticians data managers clinical team members and external vendors to ensure timely and high-quality deliverables.
Review Statistical Analysis Plans (SAP) with biostatisticians to anticipate any complications or complexities for programming activities.
Perform quality control (QC) and validation of internally and externally developed datasets and outputs adhering to company SOPs and programming best practices.
Integrate data across multiple studies for pooled analyses submission packages or visual summaries to support regulatory filings or internal strategy.
Document all programming activities clearly and thoroughly supporting reproducibility and regulatory compliance in a validated programming environment.
Use version control systems and structured documentation to support audit readiness and collaborative programming practices.
Contribute to posters presentations or ad hoc analyses including visual data summaries using SAS graphics or other data visualization tools.
Other duties as required
Requirements
Bachelors degree or higher in Statistics Computer Science Mathematics Life Sciences or a related discipline.
5 years of experience in statistical programming within the pharmaceutical biotechnology or medical device industry.
Proficient in SAS programming (Base Macro SQL) with exposure to SAS Graph and Stat procedures; experience with R or data visualization is a plus.
Understanding of clinical trial design GxP principles and FDA/EMA regulatory requirements particularly for medical device submissions such as PMA and 510(k).
Familiarity with CDISC standards (SDTM ADaM); ability to implement standardized datasets in line with internal and industry guidelines.
Strong attention to detail problem-solving mindset and ability to work independently or in a team environment.
Effective communication skills and a collaborative approach to working with cross-functional teams
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 () or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
US: $89000- $143750 / Bay Area: $103000-$165600Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees and/or eligible dependents are 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. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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 Sick time - 40 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:Senior IC
Employment Type
Full-Time
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved