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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: USA – Arizona – Remote
Job ID: 25104109
Updated: Today

About the Role

Syneos Health is seeking a Senior Medical Editor specializing in biostatistics and statistical documentation, including Statistical Analysis Plans (SAPs) and Blinding/Unblinding Plans. This role ensures the accuracy, consistency, and regulatory compliance of high-value clinical and statistical documents supporting global clinical trials.

The position requires strong editorial expertise, advanced understanding of statistical terminology, and the ability to collaborate with global medical writing and biostatistics teams across multiple studies and therapeutic areas.


About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization operating across 110 countries with more than 29,000 employees. The company partners with global pharmaceutical, biotechnology, and medical device companies to accelerate clinical development and optimize product commercialization.

Its Clinical Development model focuses on bringing customers and patients to the center, continuously improving efficiency, quality, and operational delivery.


Key Responsibilities

  • Apply FDA, EMA, and global regulatory guidance to ensure compliance and accuracy across statistical and scientific documents.

  • Represent the editorial function on study teams and cross-functional project groups.

  • Monitor project timelines, resource requirements, and budgets; escalate risks proactively.

  • Provide technical editorial mentorship, training, and guidance to medical editors and writers.

  • Lead editorial activities for complex or large-scale deliverables, including workflow management, internal meetings, and project coordination.

  • Support medical writing teams by providing structured feedback on editorial stages and document readiness.

  • Perform advanced copyediting following AMA Manual of Style or sponsor-specific guidelines.

  • Conduct comprehensive quality reviews (QR) to ensure clarity, integrity, scientific accuracy, and submission-readiness.

  • Contribute to continuous process improvements, SOP updates, checklists, and editorial workflow enhancements.

  • Manage editorial deliverables according to client standards, internal SOPs, and agreed timelines.

  • Support compilation of regulatory submission packages when required.


Required Qualifications & Experience

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biostatistics, Biomedical Writing, English, or related discipline.

  • Minimum 5–8 years of experience in medical editing or regulatory writing within pharma, biotech, or CRO environments.

  • Demonstrated experience editing statistical documents, including SAPs and statistical methodology sections.

  • Strong understanding of clinical trial processes, statistical concepts, and regulatory submission expectations.

  • Expertise in the AMA Manual of Style and advanced editorial review methodologies.

  • Ability to manage multiple complex projects in a fast-paced, deadline-driven environment.

  • Experience mentoring junior editorial staff and collaborating with cross-functional global teams.


Compensation & Benefits

  • Base Salary Range: USD 62,000 – 108,600
    (Actual compensation depends on experience, skills, and role proficiency.)

Role-dependent benefits may include:

  • Medical, Dental, Vision insurance

  • Company car or car allowance

  • 401(k) with company match

  • Employee Stock Purchase Plan

  • Performance-based bonuses

  • Flexible PTO and sick leave in accordance with state regulations


Why Join Syneos Health

  • Involved in projects supporting 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the past 5 years.

  • Culture built on authenticity, diversity of thought, and professional respect.

  • Strong emphasis on employee development, technical training, and career progression.

  • Opportunity to work on globally impactful clinical and statistical documentation projects.


Additional Information

Job responsibilities listed are not exhaustive. Additional tasks may be assigned depending on business needs. Syneos Health fully complies with ADA requirements and offers reasonable accommodations as needed. Equivalent experience may be considered in place of listed qualifications.


Apply Now

Interested candidates can apply directly or join the Syneos Health Talent Network to receive future job updates.