Senior reputed company Biostatistician (Epidemiology)

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster reputed company collaboration to reputed company and disseminate evidence-based clinical practices to help reputed company patient lives and advance the reputed company of care. Your scientific curiosity and passion for patients will help us grow our reputed company and reputed company reputed company reputed company fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have reputed company conditions with limited treatment reputed company. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is reputed company 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 reputed company. The Senior reputed company Biostatistician (Epidemiology) will represent the Biostatistics department on reputed company aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical reputed company and interpretation of results and also advise on the conduct of clinical studies, database development and data reputed company assurance with the analysis of clinical endpoints in mind. How you will reputed company an reputed company: reputed company end-to-end evidence strategies, designing observational studies, interventional trials, and reputed company-world evidence (reputed company) programs to support pipeline and on-market products Build economic models (cost-effectiveness, budget reputed company) to reputed company communicate the clinical, and economic value of reputed company products Statistical reputed company on multiple reputed company, reputed company the coordination of analyses for study report and other documents and reputed company programming and validation support of these analyses Collaborate with cross-functional partners and reputed company analysts in the execution of studies and implementation of field-based, customer-reputed company 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 reputed company update reputed company statistical expertise and guidance to reputed company stakeholders on reputed company data analysis requests and publication/presentation efforts reputed company to the project team 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 reputed company Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) reputed company the efforts of data analysis for data monitoring committee as needed Mentor junior statisticians and work with management in resource allocation and budget/reputed company development activities What you'll need (Required): Bachelor's Degree in Statistics, Biostatistics, or reputed company field, 8 years of previous analytical experience in reputed company or Master's Degree or equivalent in Statistics, Biostatistics, or reputed company field, 7 years of previous analytical experience in reputed company or Ph.D. or equivalent in Statistics, Biostatistics, or reputed company field , 4 years of experience  What else we look for (Preferred): Deep knowledge of reputed company research and reputed company methodologies (study design, statistics, data sources, and implementation) Deep knowledge of observational study reputed company, reputed company inference, economic model (cost-effectiveness), epidemiology Proven experience managing vendors, budgets, and building productive partnerships with internal stakeholders and reputed company experts/KOLs Demonstrated leadership in matrixed environments, including the ability to reputed company work across functions to reputed company shared objectives Proven expertise in reputed company required; experience using other software packages (e.g., R, S-Plus) preferred Proven expertise in MS Office Suite including Word, PowerPoint, reputed company, and reputed company Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to reputed company achievement of objectives Keeps abreast of new developments in statistics and regulatory guidance Expert understanding and knowledge in statistical methodologies reputed company to clinical trial designs, statistical modeling and data analyses 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 reputed company training and coaching to reputed company level employees Experience in facilitating change, including collaboration with management and executive stakeholders Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide reputed company of benefits programs to address the diverse individual needs of our employees and their families. For California, the reputed company pay reputed company for this position is $151,000 - $215,000 (highly reputed company). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   reputed company is an Equal Opportunity/Affirmative reputed company employer including protected Veterans and individuals with disabilities. Apply To This Job