Senior Principal Biostatistician – Epidemiology

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee comprehensive evidence strategies by designing observational studies, interventional trials, and real-world evidence (RWE) initiatives to support both pipeline and marketed products.

• Develop economic models (cost-effectiveness and budget impact) to effectively convey the clinical and economic value of Edwards products.

• Act as the statistical lead on various clinical trials, coordinating analyses for study reports and other documentation, while providing programming and validation support for these analyses.

• Collaborate with cross-functional partners and external analysts to execute studies and implement field-based, customer-centric initiatives and partnerships (such as models, presentations, publications, and formulary/regulatory dossiers).

• Represent the Biostatistics team on multiple project/study teams, ensuring effective communication with management and team members regarding project/study status and timeline updates.

• Offer statistical expertise and guidance to both internal and external stakeholders on ad hoc data analysis requests, as well as publication and presentation efforts related to the project team.

• Research and suggest innovative statistical methodologies and approaches.

• Contribute to the enhancement, standardization, and globalization of Biostatistics processes and procedures, including the formulation of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs).

• Lead data analysis efforts for data monitoring committees as required.

• Mentor junior statisticians and collaborate with management on resource allocation and the development of budgets and timelines.

⛳️ Requirements

• Bachelor’s Degree in Statistics, Biostatistics, or a related field.

• 8 years of prior analytical experience in clinical trials; or a Master’s Degree or equivalent in Statistics, Biostatistics, or a related field with 7 years of prior analytical experience in clinical trials; or a Ph.D. or equivalent in Statistics, Biostatistics, or a related field with 4 years of experience.

• In-depth knowledge of outcomes research and RWE methodologies, including study design, statistics, data sources, and implementation.

• Profound understanding of observational study methods, causal inference, economic modeling (cost-effectiveness), and epidemiology.

• Demonstrated experience in managing vendors and budgets, along with the ability to foster productive partnerships with internal stakeholders and external experts/KOLs.

• Proven leadership skills in matrixed environments, including the capability to direct work across functions to achieve shared objectives.

• Expertise in SAS is required; familiarity with other software packages (such as R and S-Plus) is preferred.

• Proficient in the MS Office Suite, including Word, PowerPoint, Access, and Excel.

• Exceptional written and verbal communication skills, along with strong interpersonal skills for negotiating and managing relationships to achieve objectives.

• Stay updated on new developments in statistics and regulatory guidance.

• Extensive understanding of statistical methodologies related to clinical trial designs, statistical modeling, and data analyses.

• Comprehensive knowledge of regulatory guidelines (such as GCP, ICH, FDA, ISO) pertinent to the Pharmaceutical/Medical Device research setting.

• Outstanding problem-solving, organizational, analytical, and critical thinking abilities.

• Strong leadership qualities with the capacity to influence change.

• Ability to provide training and coaching to junior-level employees.

• Experience in facilitating change, including collaboration with management and executive stakeholders.

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A wide range of benefits programs designed to meet diverse individual needs.