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WHAT
IN
Biostatistician
Job
PRA International
US
-
Lenexa,
Kansas
Job Code - 7251BR
Position - FULL TIME
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to PRA International for this position!)
JOB DESCRIPTION: Biostatistician
Prepares and performs statistical analysis on all relevant projects for clients and PRA staff.
ACCOUNTABILITIES
• Designs, develops, modifies, and evaluates the technical data and infrastructure to expedite and evaluate analysis and reporting of clinical and pre-clinical studies
o Provides significant input into the preparation and review of clinical study protocols and consults in the development of case report forms (CRFs)
o Contributes to the design, analysis, and reporting of clinical studies
o Works with the functional manager and the project manager to determine resource projections and project schedules
• Performs statistical analysis and interprets results
o Prepares analysis plans and reporting specifications
o Develops, modifies, and/or implements appropriate statistical techniques for the analysis of data from clinical studies
o Works with programmers, writers, and clinicians to coordinate data summarization and analysis activities
o Prepares and reviews integrated statistical and clinical reports including summary statistics, graphics, tabulations, and raw data listings
o Consults with other statisticians on statistical methodology, study design, and data analysis
o Maintains awareness of FDA guidelines and requirements for documentation and presentation necessary for reporting of clinical trials data
• Builds and maintains strategic relations with customer groups
o Serves as primary functional representative on project teams; may assume the role of project manager
o Visits clients to discuss statistical issues
o Performs billable work in accordance with PRA's policies, procedures, and SOPs
o Represents client regarding statistical issues at regulatory meetings
o Participates in sales activities including bid defense
REQUIREMENTS - QUALIFICATIONS: Biostatistician
QUALIFICATIONS
• Knowledge of regulatory submissions requirements for human drugs, biologics and/or devices
• Knowledge of relevant to ICH statistical analysis guidelines, report writing guidelines, and regulatory submission requirements for human drugs in NA and Europe
• Experience using computerized systems (PC-Windows and WORD, Excel) and relevant software (SAS)
• Excellent written, oral communication and presentation skills
• Read, write, and speak fluent English
For Epidemiologist Only ACCOUNTABILITIES
• Designs, develops, and evaluates data for benefit-risk assessments of medical devices, drugs, and biologicals during their development and post-authorization
• Performs pharmaco-epidemological and statistical analyses and interprets results
o Prepares and reviews integrated summaries of safety and efficacy or other relevant regulatory submission documents including summary statistics, graphics, tabulations, and raw data listings
o Serves as expert on Data Monitoring Committees (non-voting or voting members)
o Supports publication generation activities
o In a senior position, effectively coaches and mentors less experienced staff members
QUALIFICATIONS
• MSc degree in epidemiology, pharmaco-epidemiology, or related field required
• Demonstrated expertise in areas such as drug development research, regulatory requirements, drug safety management, statistics, and therapeutic areas.
PRA International
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