Associate Director Biostatistics | Dublin, Ireland | Premier Research

Position:	Associate Director Biostatistics
Institution:	Premier Research
Location:	Dublin, Ireland
Duties:	Participates and contributes to the training and development of new biostatisticians; Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure; Acts as Lead Biostatistician to interact with the study team and the sponsor; Independently develops statistical analysis plans; Performs QC of TLFs, CDISC and other analysis data sets; Prepares specifications for CDISC and other analysis data sets; Acts as an independent biostatistician on DSMBs and DMCs
Requirements:	Previous experience in clinical trials design and analysis using SAS; Previous experience as supervisor/manager; Prior experience using computerized information systems preferred; Knowledge of ICH and local regulatory authority drug research and development regulations preferred; Works with internal and external customers/vendors to meet project specific goals; Identifies, monitors, documents, and tracks out-of-scope activities; Demonstrated experience in interactions with regulatory agencies (e.g., FDA, EMA, EU member states, etc.)

Text:	Associate Director Biostatistics Participates and contributes to the training and development of new biostatisticians; Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure; Acts as Lead Biostatistician to interact with the study team and the sponsor; Independently develops statistical analysis plans; Performs QC of TLFs, CDISC and other analysis data sets; Prepares specifications for CDISC and other analysis data sets; Acts as an independent biostatistician on DSMBs and DMCs Previous experience in clinical trials design and analysis using SAS; Previous experience as supervisor/manager; Prior experience using computerized information systems preferred; Knowledge of ICH and local regulatory authority drug research and development regulations preferred; Works with internal and external customers/vendors to meet project specific goals; Identifies, monitors, documents, and tracks out-of-scope activities; Demonstrated experience in interactions with regulatory agencies (e.g., FDA, EMA, EU member states, etc.)