Senior Principal Biostatistician

$145,000 - $205,000/Yr

Edwards Lifesciences - Everett, WA

Full-time - Senior

Everett, WA

Miscellaneous Manufacturing

About the position

As a Senior Principal Biostatistician in the Advanced Technology (AT) team at Edwards Lifesciences, you will play a crucial role in the clinical development process, overseeing statistical methodologies and analyses for clinical trials. This position involves collaboration with various stakeholders to ensure the integrity and quality of clinical data, while also mentoring junior statisticians and contributing to the development of standard operating procedures.

Responsibilities

• 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
• 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

Requirements

• 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

Nice-to-haves

• 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 Pharmaceutical/Medical Device research setting
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Keeps abreast of new developments in statistics and regulatory guidance
• 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
• Excellent written and verbal communication skills and interpersonal relationship skills
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including participating and presenting at meetings
• Ability to provide guidance to others on area of expertise
• 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

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address diverse individual needs of employees and their families