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Sr Biostatistician

3-5 years
Not Disclosed
10 July 8, 2025
Job Description
Job Type: Full Time 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 (Thane & Remote)


Job Summary:

IQVIA is seeking a Senior Biostatistician to lead statistical analysis for global Phase I–IV clinical trials. This role is ideal for experienced professionals with strong command over SAS, CDISC/ADaM, and regulatory compliance in drug development. You’ll be responsible for statistical strategy, data analysis planning, and driving quality deliverables for clinical research across therapeutic areas.


Key Responsibilities:

  • Lead statistical activities on clinical trials including protocol design and SAP development

  • Review CRFs, author SAPs, TLFs, and analysis datasets for regulatory reporting

  • Manage statistical deliverables, project timelines, and cross-functional team coordination

  • Perform QC on statistical outputs and validation of programming results

  • Mentor junior statisticians and support resource planning for assigned studies

  • Ensure adherence to ICH-GCP, CDISC, and IQVIA SOPs

  • Review clinical study reports and participate in client discussions

  • Contribute to study budgets, RFPs, and bid defense activities

  • Collaborate on database lock and unblinding activities as the lead statistician

  • Engage in risk mitigation and quality oversight throughout study lifecycle


Required Skills & Qualifications:

  • Master's or PhD in Biostatistics or related field

  • 3–7 years of experience in biostatistics for clinical trials

  • Proficient in SAS, CDISC/ADaM, and related statistical programming tools

  • Strong knowledge of ICH-GCP, FDA/EMA regulatory standards

  • Expertise in SAP writing, TLF generation, and CSR input

  • Familiarity with statistical software like nQuery and clinical trial methodologies

  • Strong communication, problem-solving, and project leadership skills

  • Experience working in a matrix environment and managing competing priorities


Perks & Benefits:

  • Competitive compensation package (not disclosed in JD)

  • Hybrid work flexibility

  • Leadership in global clinical trial projects

  • Continuous professional development and mentorship programs

  • Opportunity to work with cutting-edge biostatistics tools and global teams


Company Overview:

IQVIA is a global leader in clinical research and healthcare analytics, helping clients across the pharmaceutical and life sciences sectors accelerate innovation. With a footprint in over 100 countries, IQVIA combines data science, domain expertise, and technology to deliver powerful healthcare solutions.


Work Mode:

Hybrid – Based in Thane, India, with partial remote flexibility.


Call-to-Action:

Ready to lead biostatistics in global clinical trials? Apply now to join IQVIA and make a meaningful impact in healthcare innovation.