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Biostatistics Medical Writer

Clario
clario
3-8 years
preferred by company
Bangalore, India
1 May 18, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

Biostatistics Medical Writer

Location: Bengaluru, India
Job Type: Full-Time
Work Mode: Hybrid
Industry: Clinical Research | Biostatistics | Medical Writing | Drug Development | Life Sciences
Department: Biostatistics / Scientific & Medical Writing
Experience Required: 3–8+ Years (Freshers Not Eligible)
Job Reference ID: R17504

Job Overview

A leading global clinical research and healthcare technology organization is hiring a Biostatistics Medical Writer for its Bengaluru location. This opportunity is ideal for professionals with expertise in medical writing, biostatistics, clinical trial reporting, statistical analysis plans, cardiac safety reporting, regulatory documentation, and scientific communication.

The selected candidate will collaborate with biostatistics, scientific, and clinical research teams to develop high-quality regulatory and scientific documentation for global clinical trials, with a strong focus on Expert Cardiac Safety Reports, Statistical Analysis Plans (SAPs), clinical protocols, and clinical study documentation.

This role is ideal for professionals seeking career growth in biostatistical medical writing, regulatory scientific documentation, clinical trial reporting, and cardiac safety research.

Job Responsibilities

Medical Writing & Scientific Documentation

  • Create, edit, proofread, and finalize high-quality scientific and regulatory documents.
  • Develop:
    • Expert Cardiac Safety Reports
    • Statistical Analysis Plans (SAPs)
    • Clinical trial synopses
    • Clinical protocols
    • Scientific manuscripts
    • Scientific presentations
    • Clinical reporting documentation

Clinical Trial Reporting

  • Support end-to-end clinical trial scientific reporting activities.
  • Interpret study documentation including:
    • Study protocols
    • Investigator brochures
    • Scope of work documents
    • Internal study plans
  • Prepare scientifically accurate background, methodology, results, discussion, and summary sections.

Statistical Documentation Support

  • Collaborate closely with biostatistics teams to:
    • Interpret Tables, Listings, and Figures (TLFs)
    • Integrate statistical outputs into reports
    • Ensure scientific accuracy of reporting deliverables
  • Support development and review of statistical documentation aligned with study requirements.

Cardiac Safety Reporting

  • Develop and manage Expert Cardiac Safety Reports for sponsor clinical programs.
  • Support cardiac safety documentation for regulated clinical trial studies.
  • Collaborate with subject matter experts and scientific teams for data interpretation and reporting.

Quality Control & Document Compliance

  • Perform document formatting, hyperlink validation, proofreading, and medical writing quality control.
  • Ensure documentation complies with:
    • FDA regulations
    • EMA regulations
    • ICH guidelines
    • AMA style guide
    • Internal quality standards
  • Maintain audit-ready and submission-compliant documentation.

Project & Timeline Management

  • Manage assigned medical writing deliverables and timelines.
  • Track document progress through reporting phases.
  • Identify risks, delays, and communication needs proactively.
  • Maintain project trackers and reporting status updates.

Client & Cross-Functional Collaboration

  • Participate in:
    • Client teleconferences
    • Cross-functional planning meetings
    • Internal document review discussions
  • Support sponsor-facing communication related to medical writing deliverables.
  • Collaborate with:
    • Biostatistics teams
    • Scientific teams
    • Project managers
    • Clinical stakeholders

Process Improvement & Documentation Standards

  • Develop and maintain:
    • Medical writing templates
    • Style guides
    • SOPs
    • SWIs
    • Playbooks
    • Checklists
    • Quality templates
  • Identify process gaps and drive continuous improvement in document creation workflows.

Training & Team Development

  • Support onboarding and training of new team members.
  • Guide teams on documentation standards and medical writing best practices.
  • Support quality compliance training initiatives.

Educational Qualification

Preferred qualifications include:

  • M.Pharm
  • Pharm.D
  • MSc (Life Sciences / Biostatistics / Biomedical Sciences)
  • PhD
  • Biotechnology / Clinical Research / Medical Sciences background

Preferred specialization:

  • Biostatistics
  • Clinical Research
  • Life Sciences
  • Medical Writing
  • Biomedical Sciences