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Associate Director – Biostatistics

Sun Pharma
Sun Pharma
10-15 years
preferred by company
Gurgaon, Remote, India, India
1 May 14, 2026
Job Description
Job Type: Full Time Hybrid Education: Ph.D/M.S Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Associate Director – Biostatistics

Location: Gurgaon, Haryana, India / Remote / Hybrid
Employment Type: Full-Time
Department: Global Clinical Development / Biostatistics / Clinical Research & Regulatory Science
Experience Required: 10+ Years (PhD) / 15+ Years (MS)


Job Overview

A senior leadership opportunity is available for an experienced Associate Director – Biostatistics within the pharmaceutical clinical development and regulatory science domain. This role is ideal for highly experienced biostatistics professionals with expertise in clinical trial design, statistical analysis, regulatory submissions, statistical programming oversight, drug development strategy, and advanced clinical data interpretation.

The selected candidate will provide strategic biostatistical leadership across registration-focused clinical development programs, supporting trial design, execution, analysis, interpretation, and global regulatory submissions. This role requires strong scientific expertise, cross-functional collaboration, statistical innovation, and leadership in regulatory-grade clinical development environments.

This opportunity is best suited for senior professionals seeking advancement in biostatistics leadership, clinical development strategy, regulatory science, trial methodology innovation, and pharmaceutical R&D decision-making.


Key Responsibilities

Clinical Biostatistics Leadership

  • Serve as lead study biostatistician across development programs and multiple clinical studies
  • Provide strategic statistical leadership supporting global clinical development initiatives
  • Guide statistical decision-making across early and late-stage drug development programs
  • Ensure high-quality statistical support aligned with clinical and regulatory objectives

Clinical Trial Design & Statistical Strategy

  • Support design and execution of Phase I to Phase IV clinical studies
  • Develop robust statistical methodologies for registration-directed development programs
  • Contribute to study design optimization, endpoint strategy, sample size planning, and statistical decision frameworks
  • Perform simulation studies to evaluate trial design options and analytical approaches

Statistical Analysis & Study Deliverables

  • Author and review key study documents including:
    • Statistical Analysis Plans (SAPs)
    • TFL shells
    • Statistical methodology documentation
    • Submission-related analysis outputs
  • Oversee:
    • ADaM specification review
    • Statistical deliverable quality
    • TFL generation timelines
    • Study reporting statistical outputs

Clinical Data Analysis & Regulatory Support

  • Plan and execute:
    • Primary statistical analyses
    • Exploratory analyses
    • Submission-related statistical deliverables
    • Health authority response analyses
  • Provide statistical input to:
    • Clinical Study Reports (CSRs)
    • Regulatory submissions
    • Publications
    • Scientific presentations
    • Medical conference posters and symposium materials

Cross-Functional Collaboration
Collaborate closely with:

  • Clinical development teams
  • Medical affairs
  • Regulatory affairs
  • Statistical programming
  • Clinical operations
  • Data management
  • Medical writing
  • External CROs and service providers

Represent biostatistics at study team and project governance meetings.

Innovation & Methodology Development

  • Drive innovation in:
    • Statistical methodology
    • Adaptive trial design approaches
    • Analytical frameworks
    • Clinical development decision support
  • Contribute to modernization of statistical processes and scientific standards

Quality, Compliance & Process Excellence

  • Ensure compliance with:
    • Regulatory requirements
    • Internal SOPs
    • Clinical development quality standards
  • Contribute to:
    • SOP development
    • Statistical process improvement
    • Internal capability building
    • Technical training initiatives

Required Qualifications

Educational Qualifications
Candidates must hold one of the following:

  • PhD in Biostatistics or Statistics
    OR
  • Master’s Degree (MS) in Biostatistics or Statistics