Senior Clinical & Statistical Programmer

📋 Description

• Perform hands-on clinical and statistical programming activities across the clinical trial
• Develop, validate, and quality-check SDTM and ADaM datasets, specifications, tables, listings, and
• Provide advanced SAS programming support for safety, efficacy, exploratory, ad hoc, and publication
• Review clinical trial protocols, statistical analysis plans (SAPs), case report forms (CRFs), and
• Validate programming outputs, identify data or programming issues, and implement appropriate
• Review deliverables from CROs, contractors, and external collaborators to ensure quality, accuracy

🎯 Requirements

• Bachelor's degree in Biostatistics, Statistics, Computer Science, or a closely related discipline
• At least 5 years of relevant clinical and statistical programming experience in the pharmaceutical
• Demonstrated hands-on experience developing and validating clinical trial programming deliverables
• Advanced SAS programming skills and a strong understanding of statistical programming principles
• Thorough knowledge of CDISC standards, including SDTM and ADaM.
• Strong working knowledge of ICH, FDA, and Good Clinical Practice (GCP) regulations and guidelines.

🎁 Benefits

• Annual salary range of $153,000–$189,000.
• Competitive medical, dental, and vision insurance plans.
• 401(k) retirement plan through Fidelity, with a 100% employer match on the first 4% of employee
• Generous paid time off policy.
• Employee commuter benefits.
• Cell phone stipend.