Senior Medical Editor – Biostatistics & Statistical Documentation
Location: Remote, USA (Colorado)
Job ID: 25104109
Updated: Today
Overview
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions provider. The organization delivers strategic clinical development, medical affairs, and commercial services designed to accelerate customer success. Positioned at the intersection of science and operational excellence, Syneos Health drives innovation through data-driven insights and collaborative expertise.
The Senior Medical Editor – Biostatistics Documents plays a central role in the accuracy, clarity, and regulatory compliance of statistical documents such as Statistical Analysis Plans (SAP), Blinding and Unblinding Plans, and other clinical development deliverables. This position requires advanced editorial capabilities, strong regulatory understanding, and the ability to manage large, complex documentation workflows.
Key Responsibilities
• Ensure all biostatistics and statistical documents comply with FDA, EMA/EU, and international regulatory guidelines, along with sponsor-specific requirements.
• Represent the editorial function within medical writing teams, study teams, and cross-functional project groups.
• Oversee timelines, budgets, and project milestones; proactively highlight risks to medical writers, project managers, and supervisors.
• Provide editorial training, mentorship, and technical guidance to medical editors, medical writers, and global team members.
• Lead editorial activities for large and complex documentation packages, including scheduling, internal coordination, managing project-specific requirements, and quality expectations.
• Collaborate with medical writers to ensure alignment between editorial processes and scientific content.
• Execute high-level copyediting, ensuring consistency with AMA Manual of Style, internal style guides, and editorial checklists.
• Conduct detailed quality reviews to confirm scientific accuracy, clarity, and compliance with regulatory standards.
• Contribute to development and improvement of SOPs, templates, workflows, and process-enhancement tools within the editorial function.
• Manage assigned editorial projects according to medical writing SOPs, customer standards, and established timelines.
• Support the compilation and finalization of medical writing deliverables as required for regulatory submissions.
Required Qualifications & Experience
• Bachelor’s or Master’s degree in Life Sciences, Communications, English, Biostatistics, or a related field.
• Minimum 5–7 years of professional experience in medical editing, regulatory writing, statistical documentation, or scientific publishing in a CRO, pharmaceutical company, or clinical research setting.
• Strong understanding of clinical trial operations, statistical methodologies, and regulatory documentation processes.
• Advanced knowledge of AMA Manual of Style and statistical document structure (SAPs, Blinding/Unblinding Plans).
• Proven ability to lead multi-editor deliverables and manage editorial workflows in complex, cross-functional environments.
• Excellent written communication, analytical, and organization skills, with strong attention to detail.
Compensation & Benefits
Salary Range: USD 62,000 to 108,600
Compensation will vary based on experience, skills, and demonstrated proficiency.
Eligible benefits may include:
• Comprehensive medical, dental, and vision plans
• 401(k) with company match
• Employee Stock Purchase Plan
• Performance-based incentives or commission
• Flexible paid time off, including sick leave
• Additional benefits based on state regulations
About Syneos Health
Syneos Health has partnered with:
• 94% of FDA-approved novel drugs
• 95% of EMA-authorized products
• Over 200 clinical studies across 73,000 global sites
The company cultivates a diverse, inclusive workplace that supports professional growth, technical development, and a culture of authenticity. The Total Self culture empowers employees to thrive both personally and professionally.
Summary
The Senior Medical Editor – Biostatistics Documents ensures the scientific, editorial, and regulatory excellence of statistical documentation. The role includes advanced copyediting, quality review, document management, mentorship, and leadership of multi-editor deliverables. It requires strong experience in regulatory writing, statistical content, and cross-functional collaboration.
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Tallinn |Hà Nội :
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Lima |France :
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Prague |Chile :
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