Job Title
Biostatistics Medical Writer
Company: Clario (part of Thermo Fisher Scientific)
Location: Bangalore, India
Employment Type: Full-Time
Work Mode: Hybrid
Job Requisition ID: R17504
Job Overview
This role focuses on medical and statistical writing for cardiac safety and clinical trial reporting.
You will work closely with statistical and scientific teams to develop high-quality, regulatory-compliant clinical documents used in global drug development programs.
The role is critical in ensuring accurate interpretation and communication of statistical outputs in clinical trial reporting.
Key Responsibilities
1. Clinical & Scientific Document Writing
Create, edit, and finalize:
Expert Cardiac Safety Reports
Statistical Analysis Plans (SAPs)
Develop synopsis and protocol-related documentation for cardiac safety studies
2. Statistical Collaboration & Interpretation
Work with statistical teams to:
Interpret Tables, Listings, and Figures (TLFs)
Incorporate statistical outputs into reports
Write results, discussion, and summary sections
3. Project & Timeline Management
Manage assigned project deliverables and timelines
Track progress during scientific reporting phase
Contribute to team-level reporting trackers
4. Regulatory & Compliance Writing
Ensure compliance with:
FDA guidelines
EMA regulations
ICH standards
Apply AMA style guidelines in documentation
5. Document Quality Control
Edit, format, and review clinical documents
Perform QC checks before client submission
Ensure accuracy, consistency, and proper hyperlinking
6. Client & Stakeholder Communication
Participate in client teleconferences
Support document review and revision cycles with sponsors
Communicate project status, risks, and delays
7. Process Improvement & Leadership
Develop and maintain:
SOPs (Standard Operating Procedures)
Templates and style guides
Checklists and internal documentation standards
Identify process gaps and implement improvements
Train new team members and support onboarding
8. Cross-Functional Collaboration
Work closely with:
Statistical teams
Scientific teams
Project managers
Support manuscripts and scientific publications
Required Qualifications
Degree in:
Science
Healthcare-related field
Experience Required
4+ years in:
Medical writing
Scientific writing
Clinical trial reporting
Experience in:
CRO or pharmaceutical research environment
Exposure to clinical publications or regulatory writing preferred
Key Skills Required
Strong medical and scientific writing skills
Ability to interpret statistical outputs (TLFs)
Knowledge of clinical trial processes
Strong understanding of regulatory frameworks
Excellent written and verbal communication skills
Strong analytical and organizational skills
Ability to work independently and in teams
Technical Skills
Microsoft Office (Word, Excel, PowerPoint)
Adobe tools
Familiarity with document formatting and hyperlinking tools
Regulatory Knowledge
FDA guidelines
EMA regulations
ICH-GCP standards
AMA style guide (or ability to learn quickly)
Work Environment
Hybrid work model
Fast-paced clinical research environment
Collaboration with global scientific and statistical teams
Exposure to cardiac safety and clinical trial reporting
Company Overview (Clario)
Clario, part of Thermo Fisher Scientific, specializes in clinical trial data, endpoint analytics, and evidence generation.
The company focuses on:
Clinical trial data solutions
Cardiac safety and medical analytics
Scientific reporting and evidence generation
Supporting faster development of new therapies
Purpose of Role
Clario’s mission is to transform clinical research by improving evidence generation, enabling faster development of life-changing therapies for patients worldwide.
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Witney |Ontario :
Richmond Hill | Uxbridge | Australia | North York | Mississauga | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
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