Designs, plans, and executes sound statistical methodology to prepare the statistical components for Data Monitoring Committees (DMCs).
Serves as an independent reporting statistician on multiple Data Monitoring Committees (DMCs).
Develops DMC Charters.
Develops DMC statistical analysis plans and reporting specifications for simple to complex clinical studies.
Develops and describes appropriate statistical techniques for the analysis of data in a DMC statistical analysis plan.
Consults with other statisticians on statistical methodology, study design, therapeutic area details, and data analysis.
Performs statistical analyses and interprets results from simple to complex clinical studies for DMCs.
Develops or QCs analysis programs to implement techniques described in the DMC statistical analysis plan.
Assesses model assumptions for statistical analyses.
Develops and presents statistical summary reports to DMC members.
Maintains, develops, and shares knowledge of company and industry procedures and methodologies.
Performs billable work in accordance with PRA's policies, procedures, and SOPs.
Maintains in-depth knowledge of drug development process.
Maintains in-depth knowledge of SAS procedures and good programming practices.
Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses.
Trains and mentors new or junior DMC statisticians on statistical methods and PRA procedures.
Participates in sales activities, including bid defense meetings and preparation and review of estimates and proposals.
Develops in-depth knowledge of FDA and EMEA guidelines and requirements for reporting of clinical trials data for DMCs.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
PRA Health Sciences