Senior Medical Editor – Biostatistics & Statistical Documentation
Location: Remote, USA (MT)
Job ID: 25104109
Updated: Today
Overview
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial execution. With operations across 110 countries and more than 29,000 employees, the company partners with leading sponsors to accelerate the delivery of innovative therapies.
The Senior Medical Editor – Biostatistics Documents is responsible for ensuring the accuracy, clarity, and regulatory compliance of statistical and clinical documents, including Statistical Analysis Plans (SAP), Blinding and Unblinding Plans, and other biostatistics-driven deliverables.
This role requires an advanced understanding of editorial standards, regulatory guidelines, and statistical documentation used throughout clinical development.
Key Responsibilities
• Maintain strong knowledge of FDA, EMA, EU, and other global regulatory and industry guidelines to ensure documents meet or exceed compliance requirements.
• Represent the editorial function across medical writing teams, study teams, and cross-functional project groups.
• Monitor project timelines and budgets, and proactively communicate risks to medical writing leads, project managers, and supervisors.
• Provide technical editorial expertise, mentoring, and training for medical editing staff; advise study teams and medical writers on quality review and editorial best practices.
• Serve as project lead for large and complex writing or editing deliverables, coordinating team schedules, distributing requirements, and ensuring consistent implementation across the project.
• Support medical writing deliverables as part of project teams, offering feedback and ensuring content quality throughout the editorial workflow.
• Perform comprehensive copyediting per AMA Manual of Style and internal style standards, ensuring proper grammar, style, accuracy, and consistency.
• Conduct advanced quality reviews to verify scientific accuracy, data consistency, and document integrity.
• Contribute to the development and revision of SOPs, work instructions, and process-improvement tools relevant to medical editing.
• Manage assigned deliverables in accordance with client standards and internal SOPs, ensuring on-time and on-budget completion.
• May compile medical writing deliverables for regulatory or clinical submissions.
Required Qualifications & Experience
• Bachelor’s or Master’s degree in Life Sciences, English, Communications, Biostatistics, or a related scientific field.
• A minimum of 5–7 years of experience in medical editing, scientific editing, clinical research documentation, or statistical document review within the pharmaceutical or CRO industry.
• Strong understanding of statistical terminology, clinical trial methodology, and regulatory submission requirements.
• Proficiency in AMA Manual of Style and familiarity with document templates for SAPs, statistical reports, analysis plans, and related deliverables.
• Ability to lead editorial teams for complex multi-editor projects.
• Excellent communication skills, organizational skills, and attention to detail.
Compensation & Benefits
Salary Range: USD 62,000 – 108,600
Actual compensation will depend on qualifications, experience, competencies, and role-specific proficiency.
Eligible benefits may include:
• Medical, Dental, and Vision insurance
• 401(k) with company match
• Flexible Paid Time Off (PTO) and regulated sick leave
• Employee Stock Purchase Program
• Performance-based bonuses or incentives
• Additional benefits depending on work location
About Syneos Health
In the past 5 years, Syneos Health has collaborated on 94% of all FDA-approved novel therapies and 95% of EMA-authorized products, supporting over 200 studies across 73,000 sites and more than 675,000 trial participants.
Syneos Health fosters a diverse, inclusive, and people-focused culture, supporting professional development, career progression, and work–life balance.
Learn more at: syneoshealth.com
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