Principal Statistician

Job Description

Duties and Responsibilities:

• Provide statistical support in protocol development for observational studies and/or clinical trials.
• Author and review of statistical analysis plans, analysis dataset specifications, and TFL shells.
• Work with programming and other cross-functional teams in Phase-4 non-interventional study to develop CRF, validate and review the datasets and results.
• Conduct programming and analysis for Medical Affairs, RWE studies.
• Support develop abstract, poster and manuscript as deliverables.

Requirements:

• PhD or MS in Biostatistics or Statistics.
• Experience in pharmaceutical industry to provide statistical input into the study design, statistical analysis, and reporting of interventional and observational studies.
• Min 4 yrs experience with Phase-4 study, Medical Affairs study, Real World Evidence (RWE) or HEOR study.
• Min 4 yrs experience in statistical software, SAS and R.
• Min 4 yrs experience with SDTM and ADaM data standards.
• Min 4 yrs experience with Real World Data (RWD) and RWE methodologies, such as propensity score analysis, causal inference.
• Min 4 yrs experience with advanced statistical models such as mixed effect model approaches for repeated measures, Machine Learning (ML) methods.