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Manager Biostatistician

Sun Pharma
Sun Pharma
2+ years
preferred by company
Gurgaon, Remote, India, India
1 May 13, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, 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, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Job Title: Manager Biostatistician

Location: Gurgaon, Haryana, India (Remote / Hybrid)
Job Type: Full-Time
Experience Required: 2+ Years for PhD Candidates / 5+ Years for Master’s Candidates (Freshers are not eligible)
Industry: Biostatistics / Clinical Research / Pharmaceuticals / Drug Development / Life Sciences
Department: Global Clinical Development / Biostatistics

About the Role
We are seeking an experienced and highly analytical Manager Biostatistician to support global clinical development programs, registration-directed clinical trials, and regulatory submission strategies within a leading pharmaceutical research environment. This role is ideal for biostatistics professionals with strong expertise in clinical trial design, statistical analysis, regulatory submissions, data interpretation, and cross-functional drug development collaboration.

The ideal candidate will play a strategic role in designing statistically robust clinical studies, ensuring scientific rigor in data analysis, supporting global regulatory submissions, and contributing to innovation in biostatistical methodologies across the drug development lifecycle.

This opportunity is highly suited for experienced statisticians passionate about pharmaceutical R&D, advanced analytics, and regulatory science.

Key Responsibilities

Clinical Trial Design & Statistical Strategy

  • Lead development of statistical designs, analysis methodologies, and data interpretation strategies for clinical development programs.
  • Ensure study protocols and statistical approaches are scientifically rigorous, aligned with development objectives, and compliant with regulatory expectations.
  • Develop and review Statistical Analysis Plans (SAPs) to ensure methodological integrity and project alignment.
  • Contribute to the development of statistical standards, analytical frameworks, and clinical research methodologies.

Data Management & Database Collaboration

  • Collaborate with data management, data sciences, and statistical programming teams to ensure robust data collection and database implementation.
  • Support design of data collection instruments, monitoring strategies, and project-specific data standards.
  • Ensure accuracy, integrity, and readiness of clinical datasets for statistical analysis.
  • Contribute to database quality assurance and analytical readiness activities.

Statistical Analysis & Methodology Leadership

  • Perform advanced statistical analyses for clinical trial data across multiple study phases.
  • Apply statistical methodologies to optimize study efficiency, sensitivity, and scientific robustness.
  • Recommend innovative analytical techniques and methodological enhancements where appropriate.
  • Provide detailed analytical specifications to statistical programming teams for implementation.

Scientific Reporting & Publications

  • Interpret clinical study results and ensure scientific conclusions are statistically valid and clearly communicated.
  • Contribute to preparation of statistical reports, scientific publications, study summaries, and clinical documentation.
  • Provide in-depth statistical review of manuscripts, clinical reports, and publication materials.
  • Present analytical insights in management reviews, project meetings, and cross-functional discussions.

Cross-Functional Project Leadership

  • Partner with clinical development, regulatory affairs, medical teams, data management, and programming stakeholders.
  • Provide strategic statistical input to assigned clinical development projects and drug development initiatives.
  • Support clinical development strategy creation through data-driven decision-making.
  • Represent the biostatistics function in multidisciplinary project teams and governance discussions.