Role overview
**Job Title: Principal Biostatistician (Fully Remote)**
**Client: Pharmaceutical**
**Rate:** $100h on W2
**Duration: Long Term**
**Location: USA**
**Key Skills Required:** PhD or MS in Biostatistics or Statistics with 4 years of experience in the Pharmaceutical /Clinical Research Organization (CRO) industry with strong experience in Design Analysis, Phase-4 Studies(interventional or observational), Medical Affairs studies, Real World Evidence (RWE), Real World Data (RWD) or Health Economics and Outcomes Research (HEOR).
**Description:**
The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and updates.
**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.
**Job Requirements:**
**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 Evidence (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
* Min 4 yrs experience with advanced statistical models such as mixed effect model approaches for repeated measures, Machine Learning (ML) methods.
Job Type: Contract
Pay: $95.00 - $100.00 per hour
Expected hours: 8 per week
Benefits:
* Health insurance
* Paid time off
Work Location: Remote