Senior Statistical Programmer

Johnson & Johnson•Santa Clara, CA

16h•Remote

About The Position

Johnson & Johnson is hiring a Senior Statistical Programmer for its J&J MedTech Circulatory Restoration Portfolio/Solutions. This fully remote position may be based anywhere in the United States and supports the Biostatistics team in generating and validating analysis datasets and statistical outputs for clinical trials. The role contributes to implementation of programming standards and standardization of CDISC-compliant datasets, including SDTM and ADaM, across clinical programs. The work supports clinical trial reporting, regulatory submissions, and publications in a regulated environment, including medical device submissions such as PMA and 510(k).

Requirements

Bachelor’s degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline.
At least 5 years of statistical programming experience in the pharmaceutical, biotechnology, or medical device industry.
Proficiency in SAS programming, including Base SAS, Macro, and SQL, with exposure to SAS Graph and Stat procedures.
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 and ADaM) and ability to implement standardized datasets in line with internal and industry guidelines.
Strong attention to detail and problem-solving skills.
Ability to work independently and in a team environment.
Effective communication skills and a collaborative approach to cross-functional and cross-organizational work.

Nice To Haves

Experience with R or data visualization.
Interest in clinical data analysis, regulatory processes, and continual learning in a regulated environment.

Responsibilities

Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) for clinical trial reporting, regulatory submissions, and publications.
Implement and maintain standardized programming templates, macros, and tools to support consistency, efficiency, and compliance across studies.
Contribute to creating and reviewing programming specifications for SDTM- and ADaM-like datasets based on CDISC standards and internal guidelines.
Assist with programming for data cleaning, interim analyses, medical review, and final study reports.
Collaborate with statisticians, data managers, clinical team members, and external vendors to deliver timely, high-quality work.
Review Statistical Analysis Plans (SAPs) with biostatisticians and anticipate programming complexities.
Perform quality control and validation of internally and externally developed datasets and outputs according to company SOPs and programming best practices.
Integrate data across studies for pooled analyses, submission packages, and visual summaries supporting regulatory filings or internal strategy.
Document programming activities to support reproducibility and regulatory compliance in a validated programming environment.
Use version control systems and structured documentation to support audit readiness and collaborative programming.
Contribute to posters, presentations, and ad hoc analyses, including visual data summaries using SAS graphics or other data visualization tools.
Perform other duties as required.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year; 48 hours for Colorado residents and 56 hours for Washington residents.
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 a child’s birth, adoption, or foster care placement.
Bereavement Leave: 240 hours for an immediate family member and 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.