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Senior Principal Biostatistician – Epidemiology
Job Description:
- Lead end-to-end evidence strategies, designing observational studies, interventional trials, and real-world evidence (RWE) programs to support pipeline and on-market products
- Build economic models (cost-effectiveness, budget impact) to clearly communicate the clinical, and economic value of Edwards products
- Statistical lead on multiple clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses
- Collaborate with cross-functional partners and external analysts in the execution of studies and implementation of field-based, customer-focused initiatives and partnerships (e.g., models, presentations, publications, formulary/regulatory dossiers).
- Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
- Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team
- Research and recommend novel statistical methodology and/or approaches
- Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)
- Lead the efforts of data analysis for data monitoring committee as needed
- Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities
Requirements:
- Bachelor's Degree in Statistics, Biostatistics, or related field
- 8 years of previous analytical experience in clinical trials or Master's Degree or equivalent in Statistics, Biostatistics, or related field, 7 years of previous analytical experience in clinical trials or Ph.D. or equivalent in Statistics, Biostatistics, or related field , 4 years of experience
- Deep knowledge of outcomes research and RWE methodologies (study design, statistics, data sources, and implementation)
- Deep knowledge of observational study methods, causal inference, economic model (cost-effectiveness), epidemiology
- Proven experience managing vendors, budgets, and building productive partnerships with internal stakeholders and external experts/KOLs
- Demonstrated leadership in matrixed environments, including the ability to direct work across functions to deliver shared objectives
- Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus) preferred
- Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Keeps abreast of new developments in statistics and regulatory guidance
- Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
- Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
- Excellent problem-solving, organizational, analytical and critical thinking skills
- Strong leadership skills and ability to influence change
- Ability to provide training and coaching to lower level employees
- Experience in facilitating change, including collaboration with management and executive stakeholders
Benefits:
- Competitive salaries
- Performance-based incentives
- Wide variety of benefits programs to address diverse individual needs
