Senior Statistical Programmer

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); Remote; USD 106,000 - 170,000; Full time

Benefits offered by this job

Fully remote work

Competitive pay transparency

Job summary

Johnson & Johnson in the United States is seeking a Senior Statistical Programmer to join the Biostatistics team for the MedTech Circulatory Restoration portfolio. This fully remote role supports CDISC-compliant datasets and statistical outputs for clinical trials, regulatory submissions, and publications.

The ideal candidate has 5+ years of statistical programming experience in the pharmaceutical/medical device sector, expert SAS (Base/Macro/SQL), and familiarity with FDA/EMA requirements.

Qualifications

• Bachelor’s degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or related discipline.
• 5+ years of experience in statistical programming within pharma/biotech/medical device industries.
• Proficient in SAS programming (Base, Macro, SQL) with exposure to SAS Graph and Stat procedures; R or data visualization a plus.
• Understanding of CDISC SDTM/ADaM; regulatory knowledge for PMA/510(k).
• Strong attention to detail and ability to work independently or in teams.

Responsibilities

• Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures (TLFs).
• Implement standardized templates, macros, and tools for consistency and efficiency.
• Create and review programming specs for SDTM/ADaM datasets.
• Assist in data cleaning, interim analyses, medical review, and final reports.
• Collaborate with statisticians, data managers, and external vendors to ensure timely deliverables.
• Review SAP with biostatisticians to anticipate complications.
• Perform QC and validation of datasets and outputs.
• Integrate data across studies for pooled analyses and submissions.
• Document all programming activities for reproducibility and audit readiness.
• Use version control and structured docs for collaboration.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Clinical trial design

GxP/compliance

Education

Bachelor’s degree or higher in Statistics/CS/Math/Life Sciences

Tools

SAS Graph

SQL

R (data viz)

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 Senior Statistical Programmer – J&J MedTech Circulatory Restoration Portfolio/Solutions 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 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 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

• Other duties as required.

Requirements

• Bachelor’s 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 and cross-organizational teams.

For Pay info on Fully remote roles : US: $92,000 - $148,350 / Bay Area: $106,000 - $170,200

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.

If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills: Computer Programs, Data Analytics, Statistical Analysis, Statistical Interpretation

Preferred Skills: Advanced Analytics, Analytical Reasoning, Biological Sciences, Biostatistics, Clinical Trials, Data Modeling, Data Privacy Standards, Data Quality, Data Savvy, Detail-Oriented, Good Clinical Practice (GCP), Report Writing, Research Ethics, Researching, Statistical Analysis Systems (SAS) Programming, Statistics, Technologically Savvy

The anticipated base pay range for this position is : $106,000.00 - $170,200.00

Additional Description for Pay Transparency

• Subject to the terms of their respective plans, employees are 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.
• 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 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year

Co-Ops and Intern Positions

Please use the following language: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).

Positions Represented by CBA

Please use the following language: This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. The following link to general company benefits information MUST also be included in the posting: Please use the following language: For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions. .Nov