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Senior Manager – Biostatistics

Sun Pharma
Sun Pharma
5-10 years
preferred by company
Gurgaon, Mumbai, India
1 May 14, 2026
Job Description
Job Type: Full Time Education: Ph.D/M.S Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

Senior Manager – Biostatistics

Location: Gurugram, Haryana, India / Mumbai, Maharashtra, India (Hybrid)
Employment Type: Full-Time
Department: Global Clinical Development / Biostatistics / Pharmaceutical Research & Development
Experience Required: 5+ Years (PhD) / 10+ Years (Master’s Degree)


Job Overview

A senior leadership opportunity is available for an experienced Senior Manager – Biostatistics within the pharmaceutical clinical development and regulatory science domain. This role is ideal for highly skilled biostatistics professionals with expertise in clinical trial design, advanced statistical analysis, adaptive trial methodology, regulatory submissions, Bayesian statistics, and registration-focused clinical development.

The selected candidate will support the design, execution, analysis, and interpretation of global clinical trials while contributing to regulatory submission strategy and advanced statistical innovation. This role requires strong expertise in clinical development methodology, cross-functional scientific leadership, and pharmaceutical R&D decision-making.

This position is ideal for professionals seeking advancement in biostatistics leadership, clinical trial methodology, statistical innovation, regulatory strategy, and pharmaceutical development sciences.


Key Responsibilities

Biostatistics Leadership

  • Serve as lead study biostatistician across multiple clinical development programs
  • Provide strategic statistical leadership for registration-directed studies
  • Support global clinical development decision-making through advanced statistical expertise
  • Ensure timely delivery of high-quality statistical outputs aligned with development goals

Clinical Trial Design & Statistical Strategy

  • Support design and execution of Phase I to Phase IV clinical studies
  • Develop robust statistical strategies for clinical development programs
  • Contribute to:
    • Adaptive trial design methodologies
    • Bayesian statistical approaches
    • Power and sample size calculations
    • Endpoint strategy development
    • Statistical assumptions and analytical frameworks
  • Perform simulation studies to evaluate alternative study designs and analysis approaches

Statistical Analysis & Clinical Deliverables
Lead and support preparation of:

  • Statistical Analysis Plans (SAPs)
  • TFL shells
  • Statistical study documentation
  • Analytical deliverables for regulatory submissions
  • Exploratory analysis outputs

Responsibilities include:

  • Reviewing ADaM specifications
  • Overseeing ADaM dataset generation
  • Ensuring timely TLF delivery
  • Supporting Clinical Study Report (CSR) statistical content

Regulatory Submission Support

  • Support global regulatory submission programs
  • Provide statistical expertise for:
    • NDA submissions
    • BLA submissions
    • eCTD-related submission activities
    • Health authority response preparation
    • Regulatory review documentation

Scientific Communication & Evidence Generation

  • Support statistical deliverables for:
    • Publications
    • Scientific presentations
    • Medical conference posters
    • Symposium scientific materials
  • Provide statistical consultation to internal cross-functional teams

Cross-Functional Collaboration
Collaborate with:

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

Represent biostatistics in study team meetings, project governance discussions, and strategic planning forums.

Innovation & Process Excellence

  • Contribute to innovation in:
    • Statistical methodology
    • Adaptive design frameworks
    • Analytical approaches
    • Clinical trial optimization
  • Support:
    • SOP development
    • Training initiatives
    • Statistical standards enhancement
    • Process improvement programs

Required Qualifications

Educational Qualifications
Candidates must hold one of the following:

  • PhD in Biostatistics / Statistics (Preferred)
    OR
  • Master’s Degree in Biostatistics / Statistics