Edwards Lifesciences - Senior Principal Biostatistician
Location: Kirkland, Washington
About the Role:
As a Senior Principal Biostatistician in Advanced Technology (AT), you 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, and data quality assurance with the analysis of clinical endpoints in mind.
How you'll make an impact:
- Provide impact as the statistical lead on multiple clinical trials.
- Lead the coordination of analyses for study reports and other documents.
- Provide programming and validation support of these analyses.
- Collaborate with core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions.
- Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline updates.
- Research and recommend novel statistical methodology and/or approaches on clinical trial design.
- 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.
- Compile technical documents for internal and external audits.
- Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures.
- 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.
What you'll need (Required):
- Master's Degree or equivalent in Statistics, Biostatistics, or related field, plus 7 years of previous analytical experience in clinical trials.
- Ph.D. or equivalent in Statistics, Biostatistics, or related field, plus 4 years of previous analytical experience in clinical trials.
What else we look for (Preferred):
- Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling, and data analyses.
- Expert understanding of regulatory guidelines relevant to Pharmaceutical/Medical Device research.
- Excellent problem-solving, organizational, analytical, and critical thinking skills.
- Experience in facilitating change, including collaboration with management and executive stakeholders.
- Ability to provide training and coaching to junior level employees.
- Strict attention to detail and excellent written and verbal communication skills.
- Ability to manage competing priorities in a fast-paced environment.
- Proven expertise in SAS required; experience using other software packages (e.g., R, S-Plus).
- Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel.
Additional Information:
Aligning our overall business objectives with performance, 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.
For California, the base pay range for this position is $145,000 to $205,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
All patient-facing and in-hospital positions require COVID-19 vaccination as a condition of employment, unless a medical or religious accommodation is requested and granted.
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