Remote Senior Statistical Programmer (SAS/CDISC)

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

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.