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.

You will make an impact by...

• Representing the TMTT 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.

• Act as statistical lead on one or more clinical trials, lead the coordination of analyses for study reports and other documents, and provide programming and validation support of these analyses

• Statistical lead on Protocol and SAP development as well as CSRs

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

• Collaborate with statistical programming team on TLF shells development, data analysis and validation of TLFs

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

• Provide statistical expertise 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)

• Collaborate on developing case report forms and clinical database to ensure quality data collection

• Lead the efforts of data analysis for data monitoring committee as needed

What you'll need (Required):

• Ph.D. in Biostatistics, Statistics, or related; plus, 2 full years of previous biostatistics, analytical experience in clinical trials

• Master's Degree in Biostatistics, Statistics, or related; plus, 5 full years of previous biostatistics, analytical experience in clinical trials

What else we look for (Preferred):

• Medical Device experience

• Capable of independently leading pivotal trials

• Experience in trial simulations for sample size and power calculation

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

• Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

• Proven expertise in SAS and R

• Exposure to using PASS or EAST

• DMC/DSMB exposure 

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Keeps abreast of new developments in statistics and regulatory guidance

• 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

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention o