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Statistical Scientist

IQVIA
5-8 years
preferred by company
Remote, India, Thane, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology

 

Statistical Scientist

Location: Thane, India
Job Type: Full-Time
Work Mode: Home-Based / Remote
Industry: Clinical Research | Biostatistics | Pharmaceutical | CRO | Life Sciences
Experience Required: 5–8 Years (Freshers Not Eligible)
Job Reference ID: R1533390

Job Overview

A leading global clinical research and healthcare intelligence organization is hiring an experienced Statistical Scientist for its Thane, India operations. This is an excellent opportunity for mid-to-senior level biostatistics professionals with expertise in clinical trial statistics, statistical programming, protocol development, regulatory submissions, CDISC standards, SAS programming, and clinical data interpretation.

The role is ideal for professionals looking to work on complex global clinical studies, integrated submissions, statistical analysis planning, and client-facing biostatistical leadership within pharmaceutical, biotechnology, and CRO environments.

This position offers the opportunity to lead high-impact clinical research programs while collaborating with global teams and supporting innovative drug development initiatives.

Key Responsibilities

Clinical Study Statistical Leadership

  • Lead statistical activities for complex clinical studies, integrated summaries, and regulatory submissions.
  • Develop and review study protocols, case report forms (CRFs), and statistical analysis plans (SAPs).
  • Provide expert statistical guidance for study design, analysis methodology, and interpretation of clinical trial data.
  • Drive statistical discussions across internal and external stakeholder teams.

Statistical Programming & Analysis

  • Develop programming specifications for analysis datasets, statistical outputs, and efficacy analyses.
  • Oversee dataset derivations, statistical programming workflows, and analysis execution.
  • Support creation and validation of statistical datasets in compliance with regulatory standards.
  • Review analysis outputs for consistency, accuracy, and scientific integrity.

Tables, Listings & Figures (TLF) Development

  • Create and review programming specifications for tables, listings, and figures.
  • Ensure quality, consistency, and regulatory alignment of statistical outputs.
  • Support complex TLF programming and quality review processes.

Client Communication & Stakeholder Management

  • Serve as the primary statistical contact for clients.
  • Communicate effectively regarding study protocols, statistical methodologies, and analytical findings.
  • Build strong client relationships while delivering high-quality statistical consulting support.
  • Participate in operational and strategic client discussions.

Project Management & Timeline Oversight

  • Plan project timelines, resource allocation, and workload forecasting.
  • Identify scope risks, out-of-scope work, and delivery bottlenecks.
  • Support budget control and revenue recognition processes.
  • Contribute to proposal reviews, bid defenses, and request-for-proposal (RFP) activities.

Regulatory Submission & Compliance

  • Support statistical deliverables for regulatory submissions and integrated clinical reports.
  • Ensure compliance with:
    • Good Clinical Practice (GCP)
    • International Conference on Harmonisation (ICH) guidelines
    • CDISC / ADaM standards
    • Clinical research regulatory frameworks

Database Lock & Randomization Support

  • Lead database lock and unblinding processes.
  • Support randomization specification development and QC review activities.
  • Participate in data monitoring and clinical statistical oversight activities.

Mentorship & Knowledge Sharing

  • Train and mentor junior and senior statistical staff.
  • Contribute to departmental training programs and subject matter expertise initiatives.
  • Support thought leadership, conference participation, and statistical best practices development.

Required Qualifications

Educational Requirements

  • Bachelor’s Degree in Biostatistics, Statistics, Mathematics, Life Sciences, or related field
  • Master’s Degree in Biostatistics or related discipline preferred

Experience Requirements

  • 5 to 8 years of relevant experience in biostatistics, clinical research, pharmaceutical, or CRO environments
  • Proven experience supporting clinical trial statistical analysis and regulatory deliverables
  • Experience handling client-facing statistical responsibilities
  • Experience working in global clinical trial environments preferred

Required Technical Skills

  • Biostatistics
  • Clinical Trial Statistics
  • SAS Programming
  • Statistical Analysis Planning
  • CDISC / ADaM Standards
  • Sample Size Calculation
  • Data Interpretation
  • Statistical Reporting
  • Protocol Review
  • Clinical Data Analysis
  • TLF Development
  • Quality Control Review
  • Randomization Methodology
  • Regulatory Submission Support