Designs, plans, and executes biostatistical components of clinical trials. Uses sound statistical methodology to conduct studies, prepares the statistical components of protocols, and is responsible for the statistical components of reports.
Serves as the lead biostatistician on project teams for simple to moderate clinical studies.
Develops statistical analysis plans and reporting specifications for simple to moderate clinical studies.
Performs statistical analyses and interprets results from simple to moderate clinical studies.
Participates in the development and review of CRFs, edit specifications, and critical variable lists.
Performs lead review of TFLs and derived datasets for clinical studies.
Contributes to clinical study protocols and clinical study reports.
Reviews simple to moderate randomization specifications and dummy randomizations.
Participates in bid defense meetings.
Master's degree in Statistics or Biostatistics or a related field is required.
Minimum of 3 years of relevant biostatistical experience required. The biostatistician supervising the analysis and reporting of the study data will be at minimum a Biostatistician II level.
Must have successfully and substantially completed leading at least one clinical study of SAP through CSR completion, unless otherwise agreed by sponsor.
Due to the nature of early phase development, a MS Biostatistician with less than 3 years of experience may be assigned as a Study Lead if he/she has successfully and substantially completed at least 10 clinical studies of SAP through CSR completion of data from clinical trials.
Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures, and good programming practices.
Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
Displays excellent communication skills with demonstrated leadership ability.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.
PRA Health Sciences