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Associate Director of Biostatistics at IQVIA

Associate Director of Biostatistics

IQVIA Durham, NC (Onsite) Full-Time
The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables within the program. RESPONSIBILITIES AND ACCOUNTABILITIES List the essential job duties and responsibilities in order of priority or time spent on each. Include only those items that are the sole or primary reason the job exists, items that require specialized skills or training, and items that demand a significant portion of time to perform (Do not list competencies, education, training requirements, etc.). 1 Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions. 2 Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents. 3 Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations. 4 Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions. 5 Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA) 6 Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. 7 Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP. 8 Support or lead improvement initiatives within the department, organization and/or pharma industry. 9 Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at [ Link removed ] - Click here to apply to Associate Director of Biostatistics

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. [ Link removed ] - Click here to apply to Associate Director of Biostatistics />
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. [ Link removed ] - Click here to apply to Associate Director of Biostatistics />
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

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