Senior Principal, Biostatistician

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• 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 and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind.

• 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 core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed

• Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update

• Research and recommend novel statistical methodology and/or approaches

• 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, 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

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 Required or

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, Plus 4 years of previous analytical experience in clinical trials Required

What else we look for (Preferred):

• Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses

• 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 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

• Strict attention to detail

• 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, including with external represe