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Job Overview: As a Principal Biostatistician, you will liaise with cross-functional teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as a lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing analyses, preparing/reviewing reports, and responding to regulatory queries.
Key Responsibilities:
* Leadership: Serve as a biostatistical consultant, represent sponsors at regulatory meetings, participate in research, teaching, and publication activities, lead studies, review methodologies, and consult on various topics.
* Knowledge Sharing: Maintain knowledge of developments in biostatistics, serve as SME.
* Risk Management: Identify and mitigate risks to project delivery and quality.
* Lock and Unblinding Process: Lead database lock and unblinding, participate in randomization team activities.
* Statistical Expertise: Review statistical deliverables, data management, perform senior reviews, and quality control.
Requirements:
* Masters or PhD in Biostatistics or related field with relevant industry experience.
* Expertise in complex statistical methods for Phase 2-3 trials.
* Experience as a statistical lead for regulatory submissions.
* Knowledge of regulatory requirements, GCP, ICH guidelines.
* Proficiency in SAS or R, knowledge of CDISC standards.
* Excellent communication, collaboration, problem-solving skills.
* Preferred: Experience in rare diseases and immunology.
IQVIA is a leading provider of clinical research services, insights, and healthcare intelligence. Learn more at https://jobs.iqvia.com
Additional Details:
* Seniority level: Not Applicable
* Employment type: Full-time
* Job function: Research, Analyst, IT
* Industry: Pharmaceutical Manufacturing
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