Senior Medical Editor – Biostatistics & Statistical Documents
Location: Remote, USA (New Mexico)
Job ID: 25104109
Updated: Today
Position Overview
Syneos Health is seeking a highly skilled Senior Medical Editor with expertise in editing and reviewing biostatistics-driven documents, including the Statistical Analysis Plan (SAP) and Blinding & Unblinding Plans. This role supports high-quality regulatory, scientific, and clinical documentation across global drug development programs.
As a part of a fully integrated biopharmaceutical solutions organization, you will work closely with multidisciplinary teams to ensure accuracy, compliance, and editorial excellence across complex deliverables.
Key Responsibilities
Regulatory & Editorial Standards
Ensure all statistical and scientific documents comply with FDA, EMA, EU, and global regulatory guidelines.
Apply AMA Manual of Style and internal style guidelines for copyediting and quality review.
Perform advanced quality checks to maintain accuracy, data integrity, and consistency in regulatory submissions.
Cross-Functional Collaboration
Represent the editorial function in medical writing teams, project teams, and cross-departmental collaborations.
Provide structured feedback to lead medical writers on document progress and editorial alignment.
Project Management & Leadership
Lead assigned editorial deliverables for complex or large medical writing projects.
Manage timelines, budget expectations, and resource planning.
Conduct and lead internal project-specific meetings and coordinate requirements across editorial teams.
Training, Mentorship & Process Improvement
Mentor and train medical editors and medical writers on editorial standards, quality review procedures, and document compilation.
Support the development and update of internal SOPs, workflows, and editorial quality systems.
Provide technical expertise and support to editorial and medical writing teams globally.
Document Compilation
May be responsible for compiling medical writing deliverables and supporting end-to-end document development.
Experience Required
5–8 years of experience in medical editing, scientific editing, or regulatory writing within clinical research or biostatistics domains.
Proven experience editing statistical documents such as SAPs, statistical reports, TLF documentation, and related study materials.
Strong understanding of FDA/EMA/ICH guidance, global regulatory standards, and statistical terminology.
Experience leading editorial workflows or managing multi-editor deliverables is preferred.
Proficient in AMA Manual of Style and advanced editorial quality review methodologies.
Why Work at Syneos Health
Syneos Health offers a work environment focused on development, recognition, and work-life balance. Benefits may include:
Medical, Dental, and Vision coverage
401(k) with company match
Employee Stock Purchase Plan
Flexible Paid Time Off and sick leave
Car allowance or company car (based on role)
Performance-based bonus eligibility
The company is committed to fostering diversity, inclusion, and an environment where individuals can thrive authentically.
Compensation
Salary Range: USD 62,000 – 108,600 annually
Compensation is based on qualifications, skills, and demonstrated expertise.
About Syneos Health
Over the past five years, Syneos Health has contributed to:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ global clinical studies across 73,000 sites and 675,000+ trial participants
The company continues to drive innovation and excellence in clinical development, medical affairs, and commercial solutions.
Learn more at: syneoshealth.com
Additional Information
This job description outlines key responsibilities but is not exhaustive. Duties may be revised as required. Syneos Health complies fully with ADA requirements and relevant regional employment legislation. Equivalent experience or education may be considered as part of the qualification criteria.
Summary
The Senior Medical Editor ensures the highest quality of statistical, regulatory, and scientific documentation through expert copyediting, quality review, and editorial leadership. The role requires strong biostatistics understanding, regulatory familiarity, and advanced editorial capabilities.
Apply Now
Submit your application through the Syneos Health careers portal.
Not ready to apply? Join the Talent Network to stay informed about future opportunities.
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