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.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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