Job Description
Parexel is hiring a Principal Biostatistician to work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert. Location : United States - Remote Key Accountabilities Operational Execution Provide broad statistical support, including trial design, protocol and CRF development on specific studies Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review Business Development Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings General Activities Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis Understand, apply and provide training in extremely advanced and sometimes novel statistical methods Contribute to the development and delivery of internal and external statistical training seminars and courses Review