[Hiring] Senior Statistical Programmer @Johnson & Johnson Innovative Medicine

Role 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.

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.

Qualifications

• 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.

Requirements

• Computer Programs
• Data Analytics
• Statistical Analysis
• Statistical Interpretation

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year