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Biostatistics Medical Writer

Clario
clario
4+ years
preferred by company
Bangalore, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Job Title: Biostatistics Medical Writer

Location: Bangalore, Karnataka, India
Job Type: Full-Time
Experience Required: 4+ Years (Freshers are not eligible)
Industry: Clinical Research / Biostatistics / Medical Writing / Pharmaceuticals / CRO / Life Sciences
Department: Biostatistics / Medical Writing / Clinical Scientific Reporting

About the Role
We are seeking an experienced and detail-oriented Biostatistics Medical Writer to join a dynamic clinical research and scientific reporting team in Bangalore, India. This role is ideal for professionals with strong expertise in medical writing, biostatistics interpretation, clinical trial reporting, and scientific documentation within pharmaceutical, CRO, or life sciences environments.

The ideal candidate will work closely with biostatisticians, scientific experts, and cross-functional stakeholders to develop high-quality clinical and scientific documents, including Statistical Analysis Plans (SAPs), expert safety reports, clinical summaries, protocols, and regulatory-compliant scientific deliverables.

This opportunity is highly suitable for experienced professionals passionate about transforming clinical data into clear, accurate, and scientifically robust documentation.

Key Responsibilities

Medical Writing & Scientific Documentation

  • Create, edit, review, proofread, and finalize high-quality scientific and clinical documents for global clinical research programs.
  • Develop Statistical Analysis Plans (SAPs), expert clinical safety reports, clinical summaries, scientific reports, and protocol-related documentation.
  • Prepare scientifically accurate content for results sections, executive summaries, background sections, and discussion narratives.
  • Ensure consistency, clarity, scientific accuracy, and regulatory compliance across all written deliverables.

Biostatistics Interpretation & Clinical Data Reporting

  • Interpret statistical outputs including tables, figures, listings, and analytical datasets to develop clear and concise scientific narratives.
  • Collaborate with biostatistics teams to translate statistical findings into meaningful clinical reporting content.
  • Support interpretation of trial outcomes, safety data, and analysis findings for reporting purposes.
  • Ensure accurate integration of quantitative results into final deliverables.

Clinical Trial Documentation Support

  • Interpret source documents such as study protocols, investigator brochures, clinical development plans, and scientific study documentation.
  • Support development of clinical protocols, trial synopses, and associated reporting documentation.
  • Contribute to document creation across various stages of the pharmaceutical drug development lifecycle.

Regulatory Compliance & Quality Assurance

  • Ensure all documentation aligns with FDA, EMA, ICH guidelines, clinical trial reporting standards, and scientific publication best practices.
  • Perform formatting, hyperlink validation, editorial review, and document quality control checks before internal or client submission.
  • Support development and maintenance of document templates, style guides, SOPs, checklists, and writing standards.
  • Contribute to audit readiness and documentation governance initiatives.

Project Management & Cross-Functional Collaboration

  • Manage assigned writing deliverables, timelines, and reporting milestones within fast-paced clinical project environments.
  • Communicate project progress, risks, delays, and dependencies to project managers and stakeholders.
  • Participate in internal planning meetings, scientific discussions, and client interactions when required.
  • Collaborate with biostatistics, clinical operations, scientific teams, and quality stakeholders.

Training, Process Improvement & Knowledge Sharing

  • Support onboarding and mentoring of junior medical writers or new team members.
  • Assist in developing internal best practices, process improvements, templates, and documentation frameworks.
  • Identify gaps in documentation workflows and recommend efficiency improvements.
  • Contribute to scientific presentations, manuscripts, and publication support initiatives where applicable.

Required Qualifications

  • Bachelor’s or advanced degree in Life Sciences, Pharmacy, Biotechnology, Biostatistics, Medicine, Healthcare Sciences, or related scientific disciplines.
  • 4+ years of relevant experience in medical writing, scientific writing, clinical reporting, or biostatistics documentation roles.
  • Strong understanding of clinical trial processes, pharmaceutical drug development, biostatistics reporting, and regulatory documentation requirements.
  • Experience within CROs, pharmaceutical companies, biotechnology organizations, or clinical research environments preferred.
  • Ability to interpret statistical outputs and convert quantitative findings into high-quality scientific documentation.
  • Strong familiarity with FDA, EMA, ICH guidelines, AMA style standards, and medical writing best practices.
  • Excellent written communication, scientific storytelling, and document management skills.
  • Proficiency with Microsoft Office, document formatting tools, Adobe products, and scientific reporting workflows.