Description:
Principal Statistician - Real World Analytics
Remote
Shift Schedule: Eastern time zone - Morning - US time zone 8 hours/day
Duration: 12 Months Up to 2 years
Core Essential Skill sets:
1. Education: PhD or MS in Biostatistics or Statistics
2. Experience in pharmaceutical industry to provide statistical input into the study design, statistical analysis, and reporting of interventional and observational studies.
3. Min 4 yrs experience with Phase-4 study, Medical Affairs study, Real World Evience (RWE) or HEOR study.
4. Min 4 yrs experience in statistical software, SAS and R.
5. Min 4 yrs experience with SDTM and ADaM data standards.
6. Min 4 yrs experience with Real World Data (RWD) and RWE methodologies, such as propensity score analysis, causal inference.
7. Min 4 yrs experience with advanced statistical models such as mixed effect model approaches for repeated measures, Machine Learning (ML) methods.
Position Summary:
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.
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