ICON Clinical Research Principal Statistician in North Wales, Pennsylvania
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
This person will support the Medical and Scientific Affairs group at IMI, providing statistical study design and analysis planning, statistical modelling and data analysis. Projects will include biomarker qualification for clinical trial use, data mining and evaluation, statistical analysis plan development, ad hoc analysis of reader performance, development of reader performance statistical monitoring tools, and scientific and clinical trial study reports.
Overview of the role
Analyze quantitative imaging biomarker data in accordance with accepted metrological guidelines for submission to regulatory agencies for approval/qualification for use as an endpoint in a clinical trial.
Work directly with sponsor statisticians in the development of image-related analysis methodologies which may be used in submission to regulatory agencies or for internal sponsor decisions.
Provide expert advice to sponsor statisticians and imaging experts in imaging-related issues including statistical method recommendation, risk management, and parameter estimation.
Develop reader performance algorithms and tools to monitor reader performance in a clinical trial. Methods will go beyond simply measuring and reporting discordance.
Develop image analysis tools that incorporate new or novel algorithms not found in current analysis tools.
Work directly with study team operations and data management to perform necessary study team specific analyses, planned or ad hoc, advise on protocols and charters.
Be an integral member of IMI study teams including proposal writing, bid defenses, Kick-Off-Meetings, Charter development, team meetings with the sponsor, ad hoc meetings with the IMI project team and other responsibilities as appropriate. Responsibilities are primarily statistical but may include other project-related needs.
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Role Requirements* *
The individual must demonstrate a high degree of initiative in anticipation and development of statistical tools and analyses that may be needed by either IMI or the sponsor.
MS/Ph.D. Statistics or 5 years equivalent experience in a research setting involving the use of imaging in statistics.
Working knowledge of medical imaging modalities, endpoints and procedures
Working knowledge of variance component estimation and interpretation including both method of moments and maximum likelihood methods
Expert knowledge of linear mixed effects model application
Expertise in SAS or R, including macro development, is necessary
Working knowledge of image segmentation methods
Preferred: familiarity with any or all of the following: NonMEM /PROC NLMIXED, Matlab
Excellent verbal and written communication skills are required.
Must be open to possible travel (approximately 10%) domestic and/or international
Benefits of Working at ICON:
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. We provide our Financial Analysts with an excellent benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and an annual incentive plan to reward performance.
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
*ICON plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment. *