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Biostatistics Medical Writer

Clario
clario
4+ years
preferred by company
Bangalore, India
1 May 13, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines

Job Title: Biostatistics Medical Writer

Company: Thermo Fisher Scientific (Clario division)
Location: Bangalore, India
Employment Type: Full-Time
Work Model: Hybrid
Industry: Clinical Research / CRO / Biostatistics / Medical Writing / Drug Development

Job Overview

We are hiring a Biostatistics Medical Writer to support scientific documentation, cardiac safety reporting, clinical trial reporting, and statistical medical writing for global clinical research programs.

This role is ideal for professionals with strong expertise in medical writing, biostatistics interpretation, clinical trial documentation, statistical analysis plans (SAPs), scientific reporting, regulatory writing, and clinical research operations.

The successful candidate will collaborate closely with statistical and scientific teams to create high-quality, compliant, sponsor-ready clinical documents.


Key Responsibilities

Medical & Scientific Writing

Develop, edit, proofread, and finalize:

  • Expert Cardiac Safety Reports
  • Statistical Analysis Plans (SAPs)
  • Clinical synopses
  • Protocol-related scientific documentation
  • Scientific manuscripts
  • Presentation content

Ensure all deliverables meet scientific, regulatory, and quality expectations.


Cardiac Safety Reporting

  • Prepare Expert Cardiac Safety Reports using:
    • Statistical outputs
    • Tables
    • Listings
    • Figures
    • Scientific interpretations
  • Work with scientific SMEs to draft:
    • Results sections
    • Discussion content
    • Executive summaries
    • Clinical interpretations

Statistical Documentation Support

Collaborate with biostatistics teams to:

  • Create Statistical Analysis Plans
  • Edit SAP documentation
  • Review methodology sections
  • Align reporting outputs with study requirements

Strong interpretation of statistical deliverables is expected.


Clinical Trial Documentation

Interpret source materials including:

  • Study protocols
  • Investigator brochures
  • Scope of Work documents
  • Internal study plans
  • Clinical development documentation

Use clinical understanding to produce scientifically accurate content.


Statistical Interpretation

  • Analyze statistical outputs including:
    • Tables
    • Figures
    • Listings
  • Convert technical statistical findings into clear scientific narratives.
  • Support accurate interpretation for sponsor-facing documentation.

Quality Control & Document Review

Perform document quality checks including:

  • Proofreading
  • Formatting review
  • Hyperlink validation
  • Consistency checks
  • Regulatory compliance checks
  • Scientific accuracy review

Ensure audit-ready documentation quality.


Timeline & Project Management

  • Manage assigned medical writing deliverables.
  • Track milestones during reporting phases.
  • Proactively identify delays, risks, or dependencies.
  • Communicate progress with project teams.

Cross-Functional Collaboration

Partner with:

  • Biostatistics teams
  • Scientific teams
  • Project managers
  • Clinical teams
  • Sponsor stakeholders

Participate in:

  • Cross-functional planning meetings
  • Review cycles
  • Client discussions
  • Teleconferences

Protocol & Synopsis Support

Support sponsors with:

  • Clinical synopsis development
  • Protocol writing support
  • Cardiac safety scientific documentation

Regulatory Writing Compliance

Ensure alignment with:

  • FDA clinical reporting expectations
  • EMA reporting requirements
  • ICH guidelines
  • Industry documentation standards

Maintain compliant scientific reporting practices.


Templates, SOPs & Standards

Create and maintain:

  • Writing templates
  • Internal style guides
  • SOPs
  • SWIs
  • Playbooks
  • Checklists
  • Documentation standards

Support process consistency and operational excellence.


Training & Team Development

  • Train new team members.
  • Support onboarding.
  • Guide best practices in medical writing.
  • Help standardize document creation workflows.

Process Improvement

  • Identify process gaps in medical writing workflows.
  • Recommend improvements in:
    • Document creation
    • Quality control
    • Timelines
    • Team efficiency

Publication Support

Contribute to:

  • Scientific manuscripts
  • Publication writing
  • Presentation content
  • Ongoing scientific communication deliverables

Required Qualifications

Education

Degree in:

  • Life Sciences
  • Healthcare
  • Pharmacy
  • Biomedical Sciences
  • Related scientific disciplines

Experience Required

  • 4+ years of relevant industry experience

Preferred backgrounds:

  • Medical writing
  • Scientific writing
  • Clinical research
  • CRO environments
  • Pharmaceutical R&D
  • Biostatistical reporting support