Senior Medical Editor – Biostatistics & Statistical Documents
Location: Remote, USA (Indiana)
Job ID: 25104109
Updated: Today
Position Overview
Syneos Health® is a global, fully integrated biopharmaceutical solutions provider committed to accelerating customer success. Through its advanced clinical development model and comprehensive scientific expertise, Syneos Health ensures high-quality outcomes across clinical, medical affairs, and commercial operations.
The Senior Medical Editor – Biostatistics Documents is responsible for ensuring the accuracy, clarity, and regulatory compliance of statistical documentation, including Statistical Analysis Plans (SAPs) and Blinding & Unblinding Plans. This role requires strong editorial proficiency, in-depth regulatory knowledge, and the ability to lead complex documentation projects.
Key Responsibilities
• Maintain expert-level familiarity with FDA, EMA/EU, and global regulatory guidelines to ensure all statistical and medical writing documents meet compliance standards.
• Represent the editorial function within medical writing teams, clinical study teams, and cross-departmental project groups.
• Track project timelines and budgets; proactively notify medical writers, project managers, and supervisors of any risks to deliverables.
• Provide advanced technical guidance to medical editors and writers; train and mentor staff across global medical writing functions.
• Lead editorial execution for large or complex medical writing deliverables, coordinate team meetings, define project expectations, and oversee document workflow.
• Collaborate with medical writers to ensure editorial consistency and accuracy across all components of the writing process.
• Perform advanced copyediting in alignment with the AMA Manual of Style, custom style guides, and internal quality standards.
• Conduct in-depth quality reviews to ensure scientific accuracy, consistency, and regulatory compliance.
• Contribute to process improvement initiatives, development of editorial SOPs, templates, and quality tools.
• Manage assigned editorial projects in accordance with SOPs, client expectations, and established timelines.
• Support the compilation and finalization of medical writing documents for regulatory submissions when required.
Required Qualifications & Experience
• Bachelor’s or Master’s degree in Life Sciences, English, Communications, Biostatistics, or a related discipline.
• Minimum 5 to 7 years of experience in medical editing, regulatory writing, biostatistics document review, or related scientific content within a CRO, pharmaceutical, or clinical research organization.
• Strong understanding of clinical research processes, statistical methodology, and regulatory documentation workflows.
• Proven expertise in editing complex statistical documents such as SAPs and Blinding/Unblinding Plans.
• Ability to lead multi-editor teams and coordinate deliverables across large-scale projects.
• Exceptional writing, editing, analytical, and organizational skills with high attention to detail.
Compensation & Benefits
Salary Range: USD 62,000 – 108,600
Compensation will vary based on experience, skills, and demonstrated expertise.
Eligible benefits may include:
• Medical, dental, and vision insurance
• Company-matched 401(k)
• Employee Stock Purchase Plan
• Performance-based incentives or bonus eligibility
• Car allowance (where applicable)
• Flexible paid time off and sick leave as per state requirements
Syneos Health complies with all state and federal regulations regarding paid time off and employee benefits.
About Syneos Health
Over the past five years, Syneos Health has contributed to:
• 94% of FDA-approved novel drugs
• 95% of EMA-authorized products
• More than 200 clinical studies
• Research across 73,000 sites and over 675,000 trial participants
The organization prioritizes diversity, professional development, and an inclusive culture that empowers talent worldwide. Employees are encouraged to challenge the status quo and drive scientific and operational excellence.
Summary
The Senior Medical Editor – Biostatistics Documents ensures the scientific integrity and regulatory accuracy of statistical and clinical documentation. The role involves advanced copyediting, quality review, document management, mentorship, and oversight of large editorial projects. This position is ideal for experienced medical editors seeking leadership responsibilities within a global biopharmaceutical environment.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
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 :
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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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
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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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Bavaria |Bavaria :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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