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Senior Manager, Biostatistics

Sun Pharma
Sun Pharma
5+ years
preferred by company
Gurgaon, Mumbai, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

Job Title: Senior Manager, Biostatistics

Location: Gurugram / Mumbai, India (Hybrid)
Job Type: Full-Time
Experience Required: 5+ Years (PhD) or 10+ Years (Master’s Degree) — Freshers are not eligible
Industry: Biostatistics / Clinical Research / Pharmaceuticals / Drug Development / Life Sciences
Department: Global Clinical Development / Biostatistics

About the Role
We are seeking a highly experienced and strategic Senior Manager, Biostatistics to lead advanced statistical strategy, clinical trial analytics, and regulatory biostatistics support across global drug development programs. This senior leadership opportunity is ideal for professionals with deep expertise in clinical biostatistics, adaptive trial design, Bayesian methodologies, regulatory submissions, statistical programming oversight, and pharmaceutical clinical development.

The ideal candidate will play a critical role in supporting registration-focused clinical studies, regulatory submissions, scientific publications, and innovative trial design strategies while partnering closely with cross-functional clinical and regulatory teams.

This role is well suited for senior biostatistics professionals seeking leadership impact in pharmaceutical R&D and global clinical development.

Key Responsibilities

Clinical Trial Statistical Leadership

  • Serve as lead biostatistician across clinical development programs and multiple registration-focused clinical studies.
  • Provide strategic statistical leadership for study design, execution, analysis, interpretation, and clinical decision-making.
  • Support clinical development teams with robust analytical strategies aligned with regulatory and scientific objectives.
  • Contribute to development of statistically sound, efficient, and regulatory-compliant clinical trial designs.

Statistical Analysis Planning & Programming Oversight

  • Author and review Statistical Analysis Plans (SAPs), TFL shells, analysis specifications, and statistical documentation.
  • Oversee development and review of AdaM specifications, statistical datasets, TFL generation, and analytical deliverables.
  • Ensure statistical outputs are accurate, timely, high quality, and aligned with protocol objectives.
  • Collaborate with statistical programming teams to ensure successful implementation of analytical strategies.

Advanced Statistical Methodology & Innovation

  • Apply advanced statistical methodologies including Bayesian approaches, adaptive clinical trial design, power calculations, sample size estimation, and exploratory analysis techniques.
  • Conduct simulations to assess trial design options, analytical methodologies, and development scenarios.
  • Recommend innovative statistical approaches that enhance trial efficiency, sensitivity, and scientific decision-making.
  • Support methodological advancement and innovation across the biostatistics function.

Clinical Reporting, Publications & Scientific Communication

  • Provide statistical input to Clinical Study Reports (CSRs), regulatory documentation, scientific publications, medical conference presentations, and posters.
  • Support interpretation of clinical data and ensure conclusions are scientifically and statistically robust.
  • Respond to statistical queries from internal stakeholders and regulatory agencies as required.

Regulatory Submission Support

  • Support global regulatory submissions including NDA, BLA, eCTD, and health authority interactions.
  • Ensure statistical documentation meets global regulatory expectations and submission quality standards.
  • Provide statistical expertise for health authority responses and submission strategy discussions.

Cross-Functional Collaboration & Leadership

  • Partner closely with clinical development, medical affairs, regulatory affairs, statistical programming, data management, and external stakeholders.
  • Participate in project governance meetings and provide data-driven strategic recommendations.
  • Drive collaboration across multidisciplinary teams to support efficient study execution and regulatory readiness.

Process Excellence & Capability Development

  • Contribute to SOP development, statistical process improvement, technical innovation, and departmental best practices.
  • Support internal training initiatives and enhancement of statistical expertise across teams.
  • Foster a collaborative, performance-driven, and scientifically rigorous work environment.

Required Qualifications

  • PhD in Biostatistics, Statistics, or related quantitative discipline with 5+ years of pharmaceutical industry experience, OR
  • Master’s degree in Biostatistics, Statistics, or related field with 10+ years of relevant experience.
  • Strong expertise in clinical trial biostatistics, adaptive designs, Bayesian statistics, sample size estimation, and regulatory statistical analysis.
  • Demonstrated understanding of Phase I–IV drug development and pharmaceutical clinical research operations.
  • Proficiency in SAS, R, statistical programming workflows, and clinical analytical methodologies.
  • Experience supporting NDA/BLA/eCTD submissions and health authority interactions is highly preferred.
  • Experience in dermatology, oncology, or complex therapeutic development programs is advantageous.
  • Strong leadership, scientific communication, analytical thinking, stakeholder management, and project execution capabilities.