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Senior Manager – Biostatistics

Sun Pharma
Sun Pharma
5-10 years
preferred by company
Gurgaon, Remote, India, India
1 May 14, 2026
Job Description
Job Type: Hybrid Education: Ph.D/M.S Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding

Senior Manager – Biostatistics

Location: Gurgaon, Haryana, India / Remote / 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

An exceptional leadership opportunity is available for an experienced Senior Manager – Biostatistics within the pharmaceutical clinical development and regulatory science domain. This role is ideal for experienced biostatistics professionals with strong expertise in clinical trial design, statistical analysis, regulatory submissions, clinical data interpretation, statistical methodology, and global clinical development strategy.

The selected candidate will support registration-directed clinical development programs, driving statistical design, execution, analysis, interpretation, and regulatory submission activities across global pharmaceutical development initiatives. This role requires strong scientific expertise, regulatory understanding, analytical leadership, and collaboration across multidisciplinary clinical teams.

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


Key Responsibilities

Biostatistics Leadership

  • Serve as lead study biostatistician across multiple development programs and clinical studies
  • Provide strategic statistical expertise supporting registration-focused clinical development programs
  • Guide statistical decision-making for study design, analysis, and regulatory readiness
  • Ensure high-quality statistical deliverables within project timelines

Clinical Trial Design & Statistical Strategy

  • Support statistical planning for Phase I to Phase IV clinical studies
  • Develop statistical methodologies aligned with study objectives and regulatory expectations
  • Support endpoint strategy, sample size planning, statistical assumptions, and analytical frameworks
  • Conduct simulation analyses to evaluate study design options and methodological approaches

Statistical Analysis & Clinical Reporting
Lead development and oversight of:

  • Statistical Analysis Plans (SAPs)
  • TFL shells
  • Statistical study documentation
  • Clinical statistical outputs
  • Submission-ready analytical deliverables

Responsibilities include:

  • Reviewing ADaM specifications
  • Overseeing ADaM dataset generation
  • Ensuring timely delivery of TLF outputs
  • Supporting clinical study report statistical content

Regulatory Submission Support

  • Support global regulatory submission activities and statistical documentation
  • Provide statistical input for:
    • Clinical Study Reports (CSRs)
    • Health authority responses
    • NDA / BLA submission activities
    • Regulatory review support
    • Scientific publication deliverables
  • Support eCTD-aligned submission requirements where applicable

Exploratory Analysis & Scientific Consultation

  • Design and execute exploratory analyses
  • Provide statistical consultation to clinical and cross-functional teams
  • Support interpretation of complex clinical datasets
  • Contribute to evidence generation and analytical strategy

Cross-Functional Collaboration
Collaborate closely with:

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

Represent biostatistics in study governance meetings and strategic project discussions.

Innovation & Process Excellence

  • Contribute to innovation in:
    • Statistical methodology
    • Trial design optimization
    • Analytical best practices
    • Process modernization
  • Support:
    • SOP development
    • Training programs
    • Capability building
    • Continuous improvement initiatives

Required Qualifications

Educational Qualifications
Candidates must hold one of the following:

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