Senior Manager Biostatistician Consultant (Medtech)

TL;DR

Senior Manager Biostatistician Consultant (Medtech): Designing early and late-stage protocols and performing statistical analyses for regulatory submissions within a global CRO with an accent on SAP development and clinical trial reporting. Focus on ensuring regulatory compliance across Phase I/II/III trials and leading the organization of study deliverables.

Location: Remote in the US

Company

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

What you will do

• Contribute to the design of early and late-stage protocols across multiple therapeutic areas.
• Develop and write statistical analysis plans (SAPs) and draft protocols or amendments.
• Perform statistical analyses for interim and final reports for submission to regulatory agencies.
• Support submission activities, including the design and reporting of integrated summaries for safety and efficacy.
• Lead the organization and scheduling of study deliverables in collaboration with Statistical Programmers and Data Managers.

Requirements

• MS or PhD in Statistics or Biostatistics.
• PhD with 4+ years or MS with 9+ years of clinical trial experience in biotechnology or pharmaceutical companies.
• Hands-on experience with Phase I/II/III clinical trials.
• Proficiency in SAS programming.
• Must be based in the United States.

Nice to have

• Proficiency in R programming.
• Previous experience with regulatory submissions in the US, Europe, Japan, and other global regions.

Culture & Benefits

• Hybrid-like benefit: Ability to work directly for a single sponsor while maintaining the security of a global CRO.
• Strong focus on quality, professional development, and a supportive culture.
• Diverse and inclusive environment promoting talent from various backgrounds.
• Low industry-average turnover rates due to core value commitment.

Hiring process

• CV submission and initial screening.
• Phone interview for candidates meeting the requirements.