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Associate Director

2 months ago

United Kingdom Warman O'Brien Full time

Associate Director Biostatistics - Modern Thinking CRO - UK/Remote
We have recently partnered with this forward thinking, CRO, who are looking for biostatisticians to join their team, to expand their outreach in the UK / Europe.

Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics to manage clinical trial programs/projects from one or multiple clients.
Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
Perform semi-annual and annual performance review and develop developmental plans contributing to the performance evaluation process.
Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
Participate in the writing of trial protocols and research proposals.
Review and provide input to clinical data management deliverables
Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs).
Perform hands-on statistical analysis and modeling; maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
Perform overall quality control (QC) review on statistical deliverables before they are released to the clients.
Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
Interact with regulatory agencies and support Sponsor in new drug application.
Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.
Assist in business development activities, including but not limited to the following: provide cost estimates of statistical and programming services; participate in generation of project proposals and bid defense meetings; Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders.
D. degree in statistical science, mathematical analysis or related fields or a Master’s degree in these fields
Demonstrated exceptional ability and performance.