Senior Medical Editor – Biostatistics & Statistical Documentation
Location: Remote, USA (WA)
Job ID: 25104109
Updated: Today
Overview
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and delivering high-quality outcomes. The Senior Medical Editor – Biostatistics Documents plays a critical role in ensuring accuracy, consistency, and regulatory compliance across statistical and clinical documentation, including Statistical Analysis Plans (SAP) and Blinding/Unblinding Plans.
This role requires advanced editorial expertise, strong understanding of statistical terminology, and experience with regulatory frameworks governing clinical research.
Key Responsibilities
• Ensure all biostatistics-related documents comply with FDA, EMA/EU, and global regulatory guidelines.
• Represent the editorial function in medical writing teams, study teams, and cross-functional project groups.
• Monitor project timelines, resources, and budgets; proactively communicate risks to leadership and project managers.
• Provide editorial mentorship, training, and technical guidance to medical editors and writers across global teams.
• Lead editorial activities for large and complex deliverables, coordinating internal meetings, schedules, requirements, and workflows.
• Collaborate closely with medical writing teams and provide feedback to lead medical writers on document progress and editorial outcomes.
• Perform in-depth copyediting to ensure grammatical accuracy, clarity, and adherence to AMA Manual of Style and internal style guidelines.
• Conduct detailed quality checks to ensure scientific accuracy, consistency, and alignment with regulatory expectations.
• Support development and improvement of SOPs, editorial checklists, templates, and process enhancement tools.
• Manage assigned editorial projects in accordance with client requirements, internal SOPs, and regulatory timelines.
• May assist in compiling and finalizing medical writing deliverables for regulatory submissions.
Required Qualifications & Experience
• Bachelor’s or Master’s degree in Life Sciences, Biostatistics, English, Communications, or a related discipline.
• Minimum 5–7 years of hands-on experience in medical editing, regulatory writing, biostatistics documentation, or scientific publishing within a CRO, pharmaceutical company, or clinical research environment.
• Strong understanding of clinical trial methodology, statistical analysis concepts, and regulatory submission requirements.
• Proficiency with AMA Manual of Style, SAP templates, and statistical documentation standards.
• Demonstrated ability to lead editorial workflows, manage deadlines, and oversee multi-editor deliverables.
• Exceptional attention to detail, organizational skills, and written communication abilities.
Compensation & Benefits
Salary Range: USD 62,000 – 108,600
Actual salary will depend on qualifications, experience, and role-specific proficiency.
Eligible benefits may include:
• Medical, Dental, and Vision plans
• 401(k) with company match
• Flexible paid time off and sick leave
• Employee Stock Purchase Plan
• Performance-based bonuses or commissions
• Additional benefits depending on state-specific regulations
About Syneos Health
Syneos Health partners with leading biopharmaceutical organizations to support the development of groundbreaking therapies. Over the last five years, the company has collaborated on:
• 94% of FDA-approved novel drugs
• 95% of EMA-authorized products
• 200+ clinical studies across 73,000 sites and 675,000+ trial participants
The company fosters a culture of inclusion, innovation, and continuous professional growth, encouraging employees to challenge conventional approaches and shape the future of clinical research.
Learn more at syneoshealth.com
Summary
The Senior Medical Editor – Biostatistics Documents ensures the scientific, editorial, and regulatory quality of biostatistical deliverables. This role requires advanced editorial expertise, leadership capability, and strong alignment with industry standards for clinical and statistical documentation.
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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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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Harrogate |South Yorkshire :
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Peru | Argentina |Brazil :
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Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Rho |Jakarta :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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