Lead Statistical Programmer- CDI -M/F
Core
Lead Statistical Programmer designing and executing RCTs and RWE studies, ensuring high-quality programming support for data analysis and reporting.
Role type
Senior IC statistical programmer (pharma/biometry)
Builds
Production statistical analysis programs and regulatory documentation for clinical trials
Domain
Pharmaceutical clinical trials (RCTs) and Real-World Evidence (RWE)
Required skills
SAS, R, CDISC (SDTM, ADaM), Define, ADRG, ICH guidelines, EMA/FDA/PMDA regulations, RCT design, RWE study design
Preferred skills
Python, SQL, oncology clinical trials, EMA/FDA/PMDA submissions
Responsibilities
Design and execute RCTs and RWE studies; Develop and validate programs for data analysis and reporting; Collaborate with statisticians and data managers; Assist in selecting and evaluating subcontractors; Contribute to regulatory documents and scientific publications; Ensure biometry documentation is included in eTMF
Seniority
Senior, hands-on IC