Biostatistics Medical Writer

Clario

4+ years

preferred by company

Bangalore, India

1 May 13, 2026

Job Description

Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: CPC Certified, 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

Job Title: Biostatistics Medical Writer

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

About the Role
We are seeking an experienced and scientifically driven Biostatistics Medical Writer to support global clinical trial reporting, cardiac safety documentation, and biostatistical scientific communications within a regulated clinical research environment. This role is ideal for professionals with expertise in medical writing, biostatistics reporting, clinical trial documentation, statistical analysis plans, scientific publications, and regulatory medical writing.

The ideal candidate will collaborate closely with statistical and scientific teams to develop high-quality scientific deliverables including Expert Cardiac Safety Reports, Statistical Analysis Plans (SAPs), clinical protocols, manuscripts, and sponsor-facing documentation.

This opportunity is highly suited for experienced medical writers seeking growth in biostatistics-focused clinical research documentation and regulatory scientific communications.

Key Responsibilities

Medical Writing & Scientific Documentation

Develop, edit, proofread, and finalize Expert Cardiac Safety Reports, scientific reports, and sponsor-facing clinical documentation.
Create clear, accurate, and scientifically robust clinical research content aligned with regulatory expectations and project requirements.
Draft medical writing deliverables including clinical reports, synopsis documents, protocol components, scientific summaries, and study documentation.
Ensure consistency, quality, scientific clarity, and document compliance across all deliverables.

Biostatistics Reporting & Statistical Documentation

Collaborate with biostatistics teams to create, review, and finalize Statistical Analysis Plans (SAPs) and analytical scientific outputs.
Interpret tables, listings, figures (TLFs), statistical outputs, and study results to develop clear narrative summaries and result interpretations.
Support presentation of biostatistical findings in scientifically accurate and regulator-ready formats.
Translate complex statistical outcomes into understandable scientific narratives for sponsors and stakeholders.

Clinical Trial Documentation & Protocol Development

Interpret source materials such as study protocols, investigator brochures, scope documents, study plans, and sponsor documentation.
Support development of synopsis documents and protocol content related to cardiac safety and clinical trial execution.
Contribute to protocol refinement, study reporting frameworks, and scientific documentation strategies.

Regulatory Writing & Compliance

Ensure all documentation aligns with ICH, FDA, EMA, GCP, and pharmaceutical clinical reporting requirements.
Apply regulatory writing standards, industry best practices, and internal quality governance across deliverables.
Support audit readiness and documentation compliance activities.

Document Quality Control & Formatting Excellence

Perform document quality reviews including proofreading, formatting checks, hyperlink validation, template compliance, and consistency verification.
Ensure final deliverables meet sponsor quality standards and internal scientific documentation requirements.
Maintain document integrity and publishing readiness.

Project Management & Timeline Coordination

Manage assigned medical writing deliverables, timelines, milestones, and project responsibilities independently.
Monitor deliverable progress and proactively communicate project risks, delays, or dependencies to project managers and stakeholders.
Contribute to team trackers and project coordination workflows.

Client Interaction & Cross-Functional Collaboration

Collaborate closely with biostatistics, scientific, project management, and sponsor-facing teams.
Participate in client teleconferences, scientific review meetings, and cross-functional planning discussions.
Support document revision cycles involving internal stakeholders and external clients.

Scientific Publications & Knowledge Development

Contribute to scientific manuscripts, publications, conference presentations, and research communications where applicable.
Maintain internal style guides, templates, writing standards, and documentation best practices.
Support continuous improvement in medical writing quality and scientific reporting excellence.

Training, SOP Development & Process Excellence

Train and mentor new medical writing team members.
Support creation and maintenance of SOPs, work instructions, templates, checklists, and process documentation.
Identify process gaps and drive continuous improvement initiatives across medical writing operations.

Required Qualifications

Bachelor’s degree or higher in Life Sciences, Pharmacy, Biomedical Sciences, Healthcare, Biostatistics, Clinical Research, Medicine, or related scientific disciplines.
Minimum 4+ years of relevant industry experience in medical writing, scientific writing, biostatistics reporting, or clinical research documentation.
Strong experience in medical/scientific writing for clinical reports, publications, regulatory documentation, or pharmaceutical research communications.
Experience within a CRO, pharmaceutical company, clinical research organization, or regulated clinical environment preferred.
Ability to interpret statistical outputs, TLFs, study results, and clinical data analyses accurately.
Strong understanding of clinical trial design, SAPs, clinical protocols, drug development, and regulatory reporting standards.
Familiarity with FDA, EMA, ICH, GCP, AMA style guide, and scientific writing best practices.
Proficiency with Microsoft Office, Adobe tools, and document publishing workflows.
Excellent analytical thinking, communication, organizational, and project coordination capabilities.

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Biostatistics Medical Writer

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