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Senior Biostatistician

Iqvia
IQVIA
5-7 years
Not Disclosed
Bangalore, India
2 May 6, 2026
Job Description
Job Type: Full Time Education: Preferred Bachelor’s Degree Fields: Epidemiology Biostatistics Statistics Bioinformatics Economics Data Science Public Health Healthcare Analytics Or equivalent quantitative/scientific disciplines Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Biostatistician

Location: Bangalore, India
Job Type: Full-Time
Experience Required: Minimum 5–7 Years in Biostatistics or Clinical Research
Industry: Clinical Research / Biostatistics / Pharmaceutical


Job Overview

We are seeking a highly experienced and analytical Senior Biostatistician to lead statistical activities for complex clinical studies, integrated submissions, and global pharmaceutical research projects. The selected candidate will play a critical role in protocol development, statistical analysis planning, clinical trial data interpretation, and oversight of biostatistics deliverables while ensuring compliance with regulatory and quality standards.

This role is ideal for professionals with deep expertise in biostatistics, SAS programming, CDISC standards, clinical trial methodologies, and regulatory statistical analysis within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Biostatistics & Clinical Trial Analysis

  • Lead statistical activities for:
    • Complex clinical studies
    • Integrated summaries
    • eSubmissions
    • Regulatory reporting projects
  • Develop and review:
    • Clinical study protocols
    • Statistical Analysis Plans (SAPs)
    • Case Report Forms (CRFs)
    • Statistical specifications
  • Interpret statistical analyses and prepare statistical sections of clinical study reports.

Statistical Programming & Dataset Management

  • Develop and maintain:
    • Programming specifications
    • Analysis dataset derivations
    • Statistical analysis outputs
  • Oversee creation and validation of:
    • Tables
    • Listings
    • Figures (TLFs)
    • Analysis datasets
  • Ensure compliance with:
    • CDISC standards
    • ADaM standards
    • Regulatory guidelines
  • Perform or review sample size calculations and advanced statistical analyses for complex studies.

Project Leadership & Team Coordination

  • Serve as Lead Statistician for assigned studies and statistical projects.
  • Coordinate and guide biostatistics teams to ensure:
    • Timely delivery
    • High-quality outputs
    • SOP compliance
    • Cross-study consistency
  • Lead project meetings, timeline discussions, and resource planning activities.
  • Mentor and train junior biostatistics staff and offshore teams.

Customer & Stakeholder Management

  • Act as the primary point of contact for clients regarding:
    • Statistical analysis
    • Programming discussions
    • Study design support
    • Operational topics
  • Build and maintain strong relationships with:
    • Sponsors
    • Clinical teams
    • Project managers
    • Internal stakeholders
  • Support bid defenses, proposals, and request-for-proposal (RFP) activities.

Risk Management & Quality Oversight

  • Identify and mitigate risks related to:
    • Project delivery
    • Data quality
    • Statistical analysis
    • Timelines
  • Lead database lock and unblinding activities where required.
  • Support quality control reviews for:
    • Randomization schedules
    • Statistical deliverables
    • Data management outputs
  • Ensure adherence to:
    • GCP guidelines
    • ICH standards
    • Regulatory requirements.

Financial & Operational Management

  • Support budget management and resource forecasting activities.
  • Manage:
    • Out-of-scope negotiations
    • Revenue recognition
    • Financial planning discussions
  • Collaborate on Estimate at Completion (EAC) reporting and operational planning.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Biostatistics
    • Statistics
    • Mathematics
    • Data Science
    • Computer Science
    • Or related quantitative/scientific disciplines

Preferred Qualifications

  • Master’s Degree preferred in:
    • Biostatistics
    • Statistics
    • Data Analytics
    • Or related fields
  • Certifications or expertise in:
    • SAS Programming
    • CDISC Standards
    • Clinical Trial Statistics
    • Regulatory Biostatistics