Biostatistician-P2
Core
Support clinical trials through statistical analysis, programming, and data interpretation to support scientific decision-making and medical device safety evaluation.
Role type
Mid-level individual contributor biostatistician
Builds
Clinical study reports, statistical analysis plans, and regulatory documentation for medical device clinical trials
Domain
Medical devices / Clinical research
Required skills
SAS programming, clinical trial design, statistical analysis methodologies, sample size calculations, regulatory guidelines (FDA, GCP, ICH)
Preferred skills
SQL, electronic clinical databases, advanced statistical modeling
Technologies
SAS, SQL
Responsibilities
Generate statistical summary tables, patient data listings, and clinical trial reports using SAS; Perform quality control reviews of SAS programs; Troubleshoot complex SAS programming challenges; Compile, organize, and analyze clinical trial data; Collaborate with Clinical Sciences teams to develop clinical study designs and prepare statistical sections of protocols; Perform sample size calculations and statistical simulations; Develop statistical analysis plans and present methodologies to stakeholders; Support the interpretation of clinical trial data for manuscripts and study reports.
