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.
Gujarat :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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