Senior Biostatistician
Core
Develop and execute Statistical Analysis Plans (SAPs), perform and validate statistical analyses, and support clinical study reports and regulatory submissions for transcatheter heart valve replacement studies.
Role type
Senior Biostatistician (Clinical Trials)
Builds
Clinical study reports, regulatory submissions (PMA), and statistical analysis plans for medical device clinical evidence.
Domain
Medical Devices / Cardiovascular / Clinical Research
Required skills
Statistical Analysis Plans (SAP) development, survival and time-to-event analysis, regulatory guidelines (GCP, FDA), clinical study reporting, randomization schemes, data cleaning support, independent validation of statistical content.
Preferred skills
Bayesian statistical methods, causal inference methods, real-world data (RWD) analysis, machine learning, epidemiology background.
Technologies
SAS, R, Python (implied by programming/analysis context), clinical database systems
Responsibilities
Develop SAPs and lead execution for assigned studies; develop statistical programs for analysis accuracy; review protocols and contribute to statistical analysis sections; author results sections of clinical study reports; provide statistical input for PMA submissions; interpret results and communicate findings to stakeholders; manage statistical deliverables and timelines; participate in case report form and clinical database development.
Seniority
Senior, hands-on IC