# FSP Principal Biostatistician for RWE Research

**Company**: IQVIA
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Salary**: $111,000.00 - $309,000.00
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Principal-Biostatistician-FSP--RWE_R1570577-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_dc35a6d1-f33

## Description

We are seeking a FSP Principal Biostatistician to provide full range statistical support for drug development based on real world evidence (RWE).

You will collaborate with multi-disciplinary project teams to establish project goals and timelines, serve as statistical lead and represent Biometrics on health outcomes and epidemiology studies.

As a subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting, you will write statistical analysis plans, provide strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians.

Key responsibilities include:

- Developing high-quality study protocols, statistical analysis plans, study reports, and other study documents

- Identifying innovation opportunities for the use of RWD

- Establishing effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD

- Maintaining the highest standards of data accuracy and integrity by implementing rigorous quality control processes throughout the data handling and analysis phases

- Adapting quickly to new requirements and efficiently handling ad-hoc requests

Requirements:

- Ph.D. in Statistics, Biostatistics, or related field with 5+ years of industry experience

- Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries

- Solid hands-on experience as Project statistician with real-world data, including EMR/EHR and claims datasets

- Fluency in LOA, mock TFLs, protocol and SAP

- Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD

- Experience with CDISC ADAM datasets

- Extensive working experience with stakeholders such as medical affairs and health economics

Benefits:

- Home-based remote working opportunities

- Work/life balance as well as flexible schedules

- Collaborating with motivated, high-performance, statistical and research teams

- Technical training and tailored development curriculum

- Research opportunities that match your unique skillset

- Promising career trajectory

- Job stability: long-term engagements and re-deployment opportunities

- Focus on bringing new therapies to market rather than project budgets and change orders

- Experience with regulatory submissions

- Engaging, fast-paced environment

- Good work-life balance

## Skills

### Required
- RWE databases
- statistical analysis plans
- study protocols
- data accuracy and integrity
- SAS programming
- LOINC codes
- reimbursement and lab data interpretation
- surrogate variable algorithms
- phenotype definitions
- proxies for clinical endpoints
- advanced programming techniques
- complex analyses relevant to real-world evidence
- interpretation and communication of research results
- ICH GCP and E9
- global regulatory and HTA requirements for RWE

### Nice to have
- Understanding of payer landscape
- health economic outcomes
- value demonstration frameworks
- regulatory submissions
- HTA support
- expertise in R

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Principal-Biostatistician-FSP--RWE_R1570577-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)