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