Biostatistics Medical Writer (Clinical Research)

TL;DR

Biostatistics Medical Writer (Clinical Research): Developing Expert Cardiac Safety Reports and Statistical Analysis Plans for global sponsors with an accent on cardiac safety and clinical trial reporting. Focus on interpreting statistical outputs, ensuring FDA/EMA regulatory compliance, and leading document revision processes.

Location: Remote (Must be based in the United States or Costa Rica)

Company

hirify.global, a part of Thermo Fisher Scientific, is driven by a mission to transform lives by advancing clinical research through innovation, expertise, and collaboration.

What you will do

• Create, edit, and finalize Expert Cardiac Safety Reports and Statistical Analysis Plans based on statistical outputs.
• Interpret statistical tables, listings, and figures to write result sections, discussions, and summaries.
• Manage project tasks and timelines during the scientific reporting phase of studies.
• Ensure all documents comply with FDA/EMA regulations and AMA style guides.
• Develop and maintain document templates and internal style guides for the team.
• Lead the medical writing aspects of the document revision process and participate in client teleconferences.

Requirements

• Degree in Science or Healthcare Related Field.
• 4+ years of relevant industry experience in medical or scientific writing.
• Based in the United States or Costa Rica.
• Experience in clinical trials within a CRO or pharmaceutical research organization.
• Ability to interpret statistical outputs and fluency in medical terminology.
• Knowledge of clinical protocols, Statistical Analysis Plans, and the drug development process.

Nice to have

• Familiarity with hirify.global products and service lines.

Culture & Benefits

• Competitive compensation and retirement savings plan with company contribution.
• Comprehensive health, dental, and vision coverage.
• Paid time off and company holidays.
• Opportunity to contribute to life-changing therapies and clinical science.