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Sr Biostatistician

3-5 years
Not Disclosed
10 July 16, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, 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, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Biostatistician – Clinical Trials

Location: Thane, India
Job Type: Full-time
Work Mode: Hybrid
Salary Range: Not specified


Job Summary

IQVIA is hiring a Senior Biostatistician to support its global clinical trials in Thane, India. This role involves leadership in statistical programming, data interpretation, and development of statistical methods and reports across Phase I–IV trials. Ideal for professionals with deep expertise in SAS, GCP, CDISC, and biostatistics, this position plays a crucial role in ensuring clinical data quality and regulatory compliance.


Key Responsibilities

  • Author statistical methods for protocols and review case report forms (CRFs)

  • Prepare Statistical Analysis Plans (SAPs) and specifications for datasets and tables

  • Interpret results and write statistical sections for Clinical Study Reports (CSRs)

  • Lead statistical activities for individual studies and support project planning

  • Perform statistical QC on deliverables including SAPs, TLFs, and outputs

  • Provide statistical support in client meetings, bid defenses, and proposals

  • Ensure adherence to ICH-GCP, regulatory, and internal quality standards

  • Train and mentor junior staff and contribute to knowledge sharing

  • Oversee data management issues, protocol reviews, and lock/unblinding processes


Required Skills & Qualifications

  • Master’s or PhD in Biostatistics or related field with 3–7 years of relevant experience

  • Strong knowledge of statistical programming using SAS, CDISC/ADaM, and related tools

  • Experience with GCP, ICH guidelines, and clinical data standards

  • Familiarity with statistical software such as nQuery

  • Excellent attention to detail, communication, and documentation skills

  • Ability to lead studies independently and collaborate in matrix environments

  • Understanding of statistical methodologies for clinical trial analysis

  • Prior experience supporting regulatory submissions and audits


Perks & Benefits

  • Hybrid work model with flexibility

  • Opportunity to lead global biostatistical projects

  • Professional development and mentorship programs

  • Exposure to advanced clinical trial methodologies and tools

  • Collaborative environment with a global healthcare leader


Company Description

IQVIA is a global leader in clinical research, healthcare analytics, and technology services. With a focus on innovation, IQVIA supports life sciences companies in accelerating drug development, ensuring regulatory compliance, and improving healthcare outcomes worldwide.


Work Mode

Hybrid – Thane-based with remote flexibility.


Call to Action

Looking to drive meaningful impact in global clinical research? Apply now to join IQVIA as a Senior Biostatistician and lead critical biostatistics initiatives that shape the future of healthcare.