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Senior Medical Editor - Biostatistics Documents - Statistical Documents (Statistical Analysis Plan, Blinding & Unblinding Plan)

5-8 years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Medical Editor – Biostatistics & Statistical Documents

Location: Remote (USA – Arizona)
Job ID: 25104109
Updated: Today

Position Overview

Syneos Health is seeking an experienced Senior Medical Editor specializing in Biostatistics and statistical documentation, including the Statistical Analysis Plan (SAP) and Blinding & Unblinding Plans. This role supports high-quality scientific, regulatory, and clinical documentation for global biopharmaceutical programs.

As part of a fully integrated biopharmaceutical solutions organization, you will collaborate closely with cross-functional teams to ensure clarity, compliance, and accuracy across all deliverables. This position is ideal for professionals experienced in medical editing, biostatistics content, and regulatory writing standards.


Key Responsibilities

Editorial Excellence & Compliance

  • Ensure documents meet FDA, EU, and other regulatory and industry standards.

  • Copyedit statistical and clinical documents using AMA Manual of Style or custom style guides.

  • Conduct advanced quality reviews to ensure accuracy, consistency, and compliance with submission standards.

Cross-Functional Collaboration

  • Represent the editorial function in medical writing teams, study teams, and multi-departmental project groups.

  • Provide feedback to lead medical writers on editorial progress and document quality.

  • Lead complex or large editorial projects, including organizing requirements and coordinating team meetings.

Project Leadership & Management

  • Monitor timelines and budgets; proactively alert stakeholders if deliverables are at risk.

  • Ensure project execution aligns with SOPs and client expectations, delivered on time and within budget.

  • Compile medical writing deliverables when required.

Training, Mentorship & Process Improvement

  • Train and mentor medical editors and writers across global teams.

  • Guide teams on editorial standards, quality review processes, and document compilation best practices.

  • Contribute to enhancements in SOPs, workflows, and editorial quality systems.


Experience Required

  • Minimum 5–8 years of professional experience in medical editing, regulatory writing, or scientific documentation, preferably within clinical research or biostatistics.

  • Demonstrated expertise in editing statistical documents such as SAPs, TLF shells, and statistical reports.

  • Strong understanding of FDA/EMA guidelines, ICH standards, and global regulatory expectations.

  • Proficiency in AMA Manual of Style, style consistency, and technical terminology.

  • Prior experience leading editorial teams or managing large cross-functional writing projects is preferred.


Why Join Syneos Health

Syneos Health offers a culture focused on professional development, recognition, and work-life balance. Benefits may include:

  • Medical, Dental, and Vision coverage

  • 401(k) with company match

  • Employee Stock Purchase Plan

  • Flexible Paid Time Off and sick leave

  • Car allowance or company car (role-dependent)

  • Performance-based bonus eligibility

The organization is committed to diversity, inclusion, and supporting employees through its Total Self culture.


Salary Range

USD 62,000 – 108,600 annually
Compensation varies based on skills, experience, and role proficiency.


About Syneos Health

Syneos Health has collaborated on 94% of all FDA-approved novel drugs over the past 5 years and supported more than 200 global studies across 73,000 sites and over 675,000 trial participants. The company continues to innovate and drive excellence in clinical development and medical affairs.

Learn more at: syneoshealth.com


Summary

The Senior Medical Editor role is responsible for elevating the quality, accuracy, and regulatory compliance of statistical and scientific documents. The position requires advanced editorial expertise, leadership capability, and strong knowledge of biostatistics-related documentation.


Apply for This Role

Submit your application now through the Syneos Health careers portal.

Not ready to apply? Join the Syneos Health Talent Network to stay informed about future opportunities.