Principal Statistical Programmer (Clinical Trials)

TL;DR

Principal Statistical Programmer (Clinical Trials): Leading and supporting the programming effort to deliver technical programming and information components of clinical projects with an accent on CDISC standards and quality assurance. Focus on implementing statistical programming aspects of protocols, ensuring regulatory compliance, and managing technical deliverables for oncology studies.

Location: Must be based in the United States

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead and support the delivery of technical programming components for clinical studies and projects.
• Implement statistical programming aspects of the protocol and clinical development programs.
• Write and implement specifications while ensuring the completeness of all relevant documentation.
• Ensure high quality of deliverables and compliance with industry standards and automation usage.
• Collaborate proactively with Statisticians, Lead Programmers, Data Managers, and Study Leaders.
• Identify, communicate, and escalate risks within assigned studies and projects.

Requirements

• Bachelor's degree in Computer Science, Statistics, or related field with 5+ years of clinical programming (CDISC) experience, or a Master's degree with 6+ years.
• Required experience in Oncology therapeutic area.
• Working knowledge of ICH, Good Clinical Practices (GCP), and clinical trial processes.
• Strong communication and coordination skills to effectively influence stakeholders.
• Ability to proactively manage concurrent activities within a project.
• Must be based in the United States.

Culture & Benefits

• Supportive culture with a strong emphasis on quality and professional development.
• Opportunity to work directly for a single sponsor while maintaining the security of a global CRO.
• Inclusive environment celebrating diversity in gender, race, beliefs, and ethnicities.
• Continuous training programs to maintain high levels of competence and expertise.
• Employee stability with below-industry average turnover rates.

Hiring process

• CV submission and acknowledgement of receipt.
• Initial phone interview for candidates meeting the requirements.