OverviewWith global oversight, provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work. Serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials. Assist the Director in strategic planning and resource allocation for the department. Participate as senior statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports. Assist the Director in proposal development, project allocations, budget projections, and client presentation, as needed. Conduct independent research and teaches courses in statistical methodology as resources permit.Note: This description consolidates content from the original posting and preserves the responsibilities and qualifications as stated.ResponsibilitiesProduction of high-quality deliverables: completes and reviews complex tasks with a focus on accuracy; oversees team with the same expectations.Leadership: serve as biostatistical consultant for department and related Biostatistics teams; stay current with developments in biostatistics and trial methodology; represent clients at regulatory meetings; may participate in independent research, teaching, presentations, and manuscript preparation; may lead major projects including protocol development, analysis plans, and integrated reports; may lead studies at an operational level before SAP writing begins.Management: drive operational pieces of the business segment; provide expert review of processes; initiate methodology development for statistical standards and validation; consult on operational/statistical/therapeutic topics; may engage with regulatory agencies.Customer: primary point of contact for customers; build and maintain client relationships; consult on operational and statistical programming topics; guide client strategy on standards where applicable.Knowledge Sharing: act as SME, define training needs and strategic offerings; mentor senior staff; contribute to training materials and rollout at multiple levels.Risk Management: identify and mitigate risks to project delivery and quality; manage study-level escalations as needed; escalate as appropriate.Lock and Unblinding Process: lead database lock/unblinding processes; oversee junior staff; provide expert input on deliverables and data management, including ADaM reviews and sample size considerations.Financials: share accountability for financial success of studies; understand budgeting and pricing considerations; discuss budget assumptions with clients.Proposals: participate in sales meetings as needed; contribute to proposal and budget development at study/submission level.Other Responsibilities: ad-hoc tasks as defined by senior management; cross-functional collaboration; may perform senior biostatistical reviews where applicable.QualificationsBachelor's Degree in Biostatistics or related field with 7–10 years of relevant experience (Req) orMaster's Degree in Biostatistics or related field with 7–10 years of relevant experience (Req) orPh.D. in Biostatistics or related field with 5 years relevant experience including 2 years managing staff (Req)Typically requires 7–10 years of prior relevant experience, or equivalent combination of education, training and experience.Deep knowledge of one or more related job areas with specialty within discipline.Familiarity with complex statistical methods for Phase I–IV clinical trials.In-depth knowledge of GCP and ICH guidelines.Strong working knowledge of SAS.Excellent written and oral communication skills and interpersonal abilities.Strong problem solving and presentation skills.Sound judgment/decision making; ability to lead and motivate a team; ability to build effective working relationships.Working knowledge of CDISC/ADaM data standards.IQVIA is a leading global provider of clinical research services, insights, and healthcare intelligence. Learn more at https://jobs.iqvia.comReferrals increase your chances of interviewing at IQVIA. Get notified about new Associate Director Biostatistics jobs in Dublin, Ireland.
#J-18808-Ljbffr