Associate Director, Biostatistics

Summary: We have built a sponsor-dedicated team with a Global Rare Disease Biopharma company. Now, we are seeking to expand this team by hiring a Biostatistician at either the Principal or Associate Director level. Join this team to make a significant impact on the study success for the sponsor. Work fully within the sponsor environment, progressing with internal study initiatives over the years. Hematology is the focus of this study work.

Job Level: Principal Biostatistician or Associate Director, Biostatistics

Location: Home-based in the U.S. or Canada

Job Expectations:

• Lead components of statistical contribution to a clinical development program.
• Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
• Lead components and fully support conduct in study design, protocol development, data collection, data analysis, report and submission preparation.
• Authors or oversees authorship of Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs). Ensure rigorous approaches are taken to ensure good scientific practices as followed: proper statistical methods utilized in analysis plans, and assay methods are appropriately designed, blinded, and randomized to meet objectives.
• Provides statistical guidance/oversight to statisticians regarding requirements and GCP standards.
• Performs exploratory statistical analyses and quantifies the benefits, risks, values and uncertainties of drug research and development to make sound conclusions and propose drug development strategies.
• Makes statistical contributions to clinical study reports, including authoring of statistical methods, data interpretation Clinical Study Reports (CSRs), and manuscripts for publication / presentation.
• Support biostatistics interactions with regulatory authorities (FDA, EMA, PMDA).
• Ensure timeliness and quality of deliverables by external vendors; conduct reviews of deliverables to ensure quality.
• Act as a Thought Partner for innovative study design and clinical development plans.
• Support or lead improvement initiatives within the department and organization.

Qualifications:

• To qualify for Associate Director level - PhD with 8+ years of industry biostatistics experience. Or, MS with 11+ years of industry experience as a Biostatistician.
• To qualify for Principal level - PhD with 5+ years of industry biostatistics experience. Or, MS with 8+ years of industry biostatistics experience.
• Experience providing statistical leadership at a study level, especially the area of study design.
• Demonstrated statistical contributions in facilitating and optimizing clinical development.
• Experience supporting regulatory interactions or submissions is preferred.
• Expertise in statistical methodologies in the context of clinical development.
• Good working knowledge in SAS and/or R.

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