GCM Evidence Generation Study Design & Execution Lead
Core
Lead statistical design and execution for evidence generation studies, including real-world data (RWD) analysis, study design support, and programming for regulatory and payer submissions.
Role type
Senior biostatistician (study design & execution lead)
Builds
Evidence generation studies, real-world evidence (RWE) analyses, and regulatory/HTA submissions
Domain
Biopharmaceuticals, Real-World Evidence (RWE), Health Economics and Outcomes Research (HEOR)
Required skills
SAS, R, Python, SQL, epidemiology, outcomes research, CDISC standards, ADaM, PICO framework, network meta-analysis, IPTW, sample size calculation, bias testing, intercurrent events modeling
Preferred skills
Machine learning for responder analyses, external controls, health economic modeling, Phase IV trial experience
Technologies
SAS, R, Python, SQL, EHR/EMR, Claims data, registries, observational databases
Responsibilities
Develop statistical analysis plans (SAP) and study protocols for RWD and interventional studies; execute analyses and generate tables, listings, and figures (TLFs); validate statistical models for competing risks and multiple comparisons; review protocols for statistical consistency; document methodology and assumptions for audit; QC outputs from other statisticians.
Seniority
Senior, hands-on IC