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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: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

Associate Director – Biostatistics

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


Job Overview

A strategic 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 accomplished biostatistics professionals with expertise in clinical trial design, statistical analysis, regulatory submissions, biostatistical strategy, drug development analytics, and cross-functional clinical leadership.

The selected candidate will play a critical role in supporting registration-focused global clinical development programs, driving statistical design, execution, analysis, interpretation, and regulatory submission readiness. This position requires deep technical biostatistics expertise, strong regulatory knowledge, scientific leadership, and experience collaborating across global clinical development functions.

This opportunity is highly suited for senior professionals seeking advancement in biostatistics leadership, clinical development strategy, pharmaceutical R&D, regulatory science, and statistical innovation.


Key Responsibilities

Biostatistics Leadership

  • Serve as lead study biostatistician across multiple development programs and clinical studies
  • Provide strategic statistical expertise across registration-focused clinical development initiatives
  • Support scientific decision-making for clinical trial design, analysis, and regulatory strategy
  • Ensure statistical deliverables meet quality, timeline, and compliance expectations

Clinical Trial Design & Statistical Strategy

  • Support statistical planning and execution for Phase I to Phase IV clinical studies
  • Design and evaluate statistical methodologies aligned with study objectives
  • Contribute to trial design optimization, endpoint strategies, sample size considerations, and analysis frameworks
  • Perform simulation studies to assess study design alternatives and analytical approaches

Statistical Analysis & Study Deliverables
Lead and support preparation of:

  • Statistical Analysis Plans (SAPs)
  • TFL shells
  • Statistical methodology documents
  • Clinical analysis outputs
  • Submission-ready statistical deliverables

Responsibilities include:

  • Reviewing ADaM specifications
  • Overseeing ADaM dataset generation
  • Ensuring timely and high-quality TLF deliverables
  • Supporting study-level analytical execution

Regulatory Submission Support

  • Support global regulatory submission activities and statistical response preparation
  • Provide statistical expertise for:
    • Clinical Study Reports (CSRs)
    • Health authority queries
    • NDA / BLA submission activities
    • Publication and scientific dissemination deliverables
  • Contribute to eCTD-aligned submission readiness where applicable

Exploratory Analysis & Scientific Consultation

  • Plan and execute exploratory statistical analyses
  • Provide statistical consultation across cross-functional teams
  • Support data-driven interpretation and clinical decision-making
  • Contribute to scientific evidence generation strategies

Cross-Functional Collaboration
Work closely with:

  • Clinical development
  • Regulatory affairs
  • Medical affairs
  • Statistical programming
  • Clinical operations
  • Data management
  • Medical writing
  • External research and service partners

Represent biostatistics in cross-functional governance and study team discussions.

Innovation & Process Excellence

  • Contribute to innovation in:
    • Statistical methodology
    • Trial design optimization
    • Analytical frameworks
    • Biostatistics best practices
  • Support:
    • SOP development
    • Process improvements
    • Training initiatives
    • Statistical capability enhancement

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