Senior Medical Editor – Biostatistics & Statistical Documentation
Location: Remote, USA (UT)
Job ID: 25104109
Updated: Today
Overview
Syneos Health® is a global, integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial execution. With presence in more than 110 countries and a workforce of over 29,000, the company partners with leading pharmaceutical and biotechnology sponsors to accelerate clinical outcomes.
The Senior Medical Editor – Biostatistics Documents is responsible for ensuring accuracy, clarity, and regulatory compliance across statistical and clinical documentation, including Statistical Analysis Plans (SAP) and Blinding/Unblinding Plans. This position requires advanced editorial expertise combined with strong understanding of regulatory standards, statistical concepts, and clinical trial documentation workflows.
Key Responsibilities
• Ensure all biostatistics-related documents comply with FDA, EMA, EU, and other international regulatory guidelines and industry standards.
• Represent the editorial function within medical writing teams, study teams, and cross-departmental project groups.
• Track timelines and budgets for assigned deliverables; proactively communicate risks to writing leads, project managers, and supervisors.
• Provide technical editorial guidance, training, and mentorship for medical editors and medical writers; advise teams on editorial standards and quality review processes.
• Lead editorial activities for large or complex medical writing deliverables, coordinating project meetings, requirements, schedules, and internal communications.
• Collaborate with medical writing teams on projects involving scientific and regulatory documents; provide feedback to lead medical writers on editorial progress.
• Perform copyediting following AMA Manual of Style and internal style guidelines, ensuring accuracy in grammar, punctuation, terminology, clarity, and consistency.
• Conduct detailed quality reviews to verify the scientific accuracy and internal consistency of assigned documents.
• Support development and improvement of SOPs, workflows, and process-enhancement tools relevant to medical editing.
• Manage assigned editorial deliverables based on client requirements and internal SOPs, ensuring timely, high-quality, and compliant output.
• May assist in compiling final medical writing deliverables for regulatory submissions.
Required Qualifications & Experience
• Bachelor’s or Master’s degree in Life Sciences, Biostatistics, English, Communications, or a related scientific discipline.
• Minimum 5–7 years of professional experience in medical editing, scientific documentation, regulatory writing, or statistical document review within a pharmaceutical, CRO, or clinical research environment.
• Strong understanding of statistical terminology, clinical trial methodology, and regulatory submission frameworks.
• Proficiency with AMA Manual of Style and statistical document templates, including SAPs and related deliverables.
• Proven experience leading editorial activities on complex, multi-editor projects.
• Exceptional attention to detail, organizational skills, and written communication skills.
Compensation & Benefits
Salary Range: USD 62,000 – 108,600
Compensation varies based on education, relevant experience, technical competencies, and role-specific proficiency.
Eligible benefits may include:
• Medical, Dental, and Vision coverage
• 401(k) with company match
• Flexible Paid Time Off (PTO) and sick leave
• Employee Stock Purchase Plan
• Performance-based bonuses or commissions
• Additional benefits subject to state and municipal regulations
About Syneos Health
Over the past 5 years, Syneos Health has partnered on 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and supported over 200 global studies involving 73,000 clinical sites and more than 675,000 trial participants.
The organization promotes a culture built on diversity, inclusion, continuous learning, and authentic collaboration. Employees are encouraged to challenge conventions and contribute to meaningful scientific advancements.
Learn more at syneoshealth.com
Summary
The Senior Medical Editor – Biostatistics Documents is responsible for high-quality editorial review, document integrity, and regulatory compliance for statistical and clinical deliverables. This role requires advanced editorial expertise, leadership capability, and strong understanding of biostatistics documentation used in global clinical research programs.
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Ranchi |Sikkim :
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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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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 :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Prague |Chile :
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