Senior Principal Biostatistician (Epidemiology)

About the role

As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. The Senior Principal Biostatistician (Epidemiology) will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results. You will also advise on the conduct of clinical studies, database development, data quality assurance, and the analysis of clinical endpoints.

Responsibilities

• 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.
• Serve as statistical lead on multiple clinical trials, coordinate analyses for study reports and other documents, and provide programming and validation support for 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 updates.
• Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts.
• 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 data analysis efforts for data monitoring committees 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, with 8 years of previous analytical experience in clinical trials, or
• Master's Degree or equivalent in Statistics, Biostatistics, or related field, with 7 years of previous analytical experience in clinical trials, or
• Ph.D. or equivalent in Statistics, Biostatistics, or related field, with 4 years of experience.

Preferred Qualifications

• Deep knowledge of outcomes research and RWE methodologies (study design, statistics, data sources, and implementation).
• Deep knowledge of observational study methods, causal inference, economic modeling (cost-effectiveness), and 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 the ability to drive achievement of objectives.
• Keeps abreast of new developments in statistics and regulatory guidance.
• Expert understanding and knowledge of 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 Pharmaceutical/Medical Device research settings.
• 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.

Pay

For California, the base pay range for this position is $151,000 - $215,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Benefits

We offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.