Manager, Statistical Programming (Clinical)

TL;DR

Manager, Statistical Programming (Clinical): Leading and supporting programming activities for clinical studies with an accent on CDISC standards, oncology/hematology therapeutic areas, and regulatory submissions. Focus on developing TFLs, ensuring compliance with ICH/GCP guidelines, and driving automation to support clinical study reports.

Location: Must be based in the United States

Company

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

What you will do

• Lead and support all programming activities per project strategies.
• Develop Tables, Figures, and Listings (TFLs) for Clinical Study Reports (CSR) and regulatory submissions.
• Customize outputs and graphics according to delivery specifications.
• Program independently with high efficiency and quality.
• Contribute to the development of best practices to improve quality and automation.
• Communicate and escalate risks within assigned studies and projects.

Requirements

• Must be based in the United States
• Bachelor’s degree in CS, statistics, or related field with 6+ years of clinical programming (CDISC) experience, or Master’s degree with 8+ years.
• Proven experience in Oncology/Hematology therapeutic areas.
• Hands-on experience with ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy).
• Working knowledge of ICH, Good Clinical Practices (GCP), and clinical drug development processes.
• Strong communication and coordination skills to work in a client-facing environment.

Culture & Benefits

• Opportunity to work for a global CRO with a focus on professional development.
• Supportive culture with a focus on quality and employee training.
• Below industry average turnover rates.
• Equal opportunity employer committed to diversity and inclusivity.

Hiring process

• Submission of CV.
• Phone interview as the first step for qualified candidates.