Statistical Scientist
Location: Kochi, India
Job Type: Full Time
Job ID: R1459847
Job Description
IQVIA is hiring a Statistical Scientist to lead and oversee the design, execution, and delivery of complex statistical projects across multiple clinical studies. This position requires strong statistical leadership, client communication, risk management, and the ability to develop and review high-quality statistical deliverables in compliance with regulatory standards.
Key Responsibilities
Project Leadership & Client Engagement
Serve as the lead statistician for complex studies, integrated summaries, or eSubmissions.
Act as the primary point of contact for clients on all statistical matters.
Manage client expectations, resolve issues, and provide statistical consultation.
Lead database lock and unblinding activities; attend DMCs when required.
Statistical Analysis & Programming
Design statistical analysis plans and develop specifications for TLFs and analysis datasets.
Write and maintain programming specifications with a focus on efficacy endpoints.
Provide oversight for dataset derivation, including complex domain creation.
Review and program complex TLFs and ensure consistency across outputs.
Quality Assurance & Risk Management
Ensure high-quality deliverables by overseeing QC checks and following SOPs.
Identify, communicate, and mitigate project risks.
Handle most study-level escalations, ensuring minimal client disruption.
Financial Management
Control study costs and support revenue recognition.
Understand project scope and budget and handle out-of-scope work negotiations.
Contribute to financial forecasting and EAC reporting.
Proposal Support & Training
Contribute to RFPs, bid defenses, and budget reviews.
Mentor and train junior statisticians, promote knowledge sharing, and act as a subject matter expert (SME).
Support development of new training materials and internal statistical capabilities.
Qualifications
Education: Master’s Degree in Biostatistics or related field (PhD preferred).
Experience: 5–7 years of relevant statistical experience in clinical research.
Skills:
Strong knowledge of SAS, CDISC/ADaM standards, and statistical computing packages (e.g., nQuery).
Expertise in statistical methodology applied to clinical trials.
Exceptional writing and communication skills.
Excellent organizational and multi-tasking ability.
Proven leadership in managing statistical teams and timelines.
Deep understanding of GCP and ICH guidelines.
About IQVIA
IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services, dedicated to improving healthcare outcomes through innovative partnerships and data-driven insights. Visit IQVIA Careers to learn more.
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