Senior Principal Statistician

Senior Principal StatisticianAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.Position Summary:Reporting to the Vice President, Clinical Affairs and Biometrics, the Senior Principal Statistician is responsible for providing Statistics/Statistical Programming services. The Senior Principal Statistician will work closely with regulatory, scientific affairs, health economics, medical affairs and other departments to ensure optimal study designs, data collection and analysis for regulatory agencies and other stakeholders. This individual will be responsible for statistical programming deliverables: SAP, derived datasets, Tables, Figures and Listings.The Senior Principal Statistician will establish and ensure compliance with standard processes and industry best practices.Essential Functions of the Position:Supports the design, analysis, and reporting of trial resultsDevelops statistical methodology for studies, including power analysis, randomization schemes, and statistical analysis plan, subgroup analysis, interim analysis, etc.Ensures data collection instruments are designed to capture protocol-specified scientific information and study databasesEffectively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, and regulatory agenciesDevelops program verification procedures and plans to provide thorough and detailed reviews of documentation and analysis outputDelivers appropriate, accurate and understandable line listings and statistical tables, and preparation and review of statistical sections of study reports and submission reviewsProgramming and validation of derived datasets Tables, Figures and ListingsOversees work of statistical programmer and CRO/vendor deliverablesManages statistics/statistical programming resources to meet assigned project prioritiesContributes to development of timelines and budgets across functional teams to ensure timely submissions aligned with our objectivesWorks in close collaboration with Data Management and contributes to the development of CRFs. DMP and other DM deliverablesProvides statistical input and review for APRs, CSRs, publications to ensure the accuracy of the statistical component of scientific reports with high qualityDevelops and routinely reviews Statistics/Statistical Programming SOPs to ensure adequate processes are in place to manage quality work in line with regulations.Participates in regulatory submission process, including IDEs and 510(k)Hires, mentors, manages and evaluates activities of statistics/programming personnel as necessaryManages personnel by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are completed on time with high qualityAdditional Essential Functions of the Position:Regular and predictable work performanceAbility to work under fast-paced conditionsAbility to make decisions and use good judgmentAbility to prioritize various duties and multitask as requiredAbility to successfully work with othersAdditional duties as assignedBasic Qualifications:MS/PhD in Statistics, Biostatistics or a related field. At least 3-5 years (PhD) or 6-10 years (MS) experience in medical device, biotech or pharmaceutical development. Minimum of 2 years of management experience. Knowledge of statistical methodology. Expertise in medical device product development and experience interacting with regulatory agencies highly desirableGood communication skills, both oral and writtenKnowledge of design, data analysis methodology, SAS programming to meet FDA and ICH guidelinesKnowledge of programming Tables, Listings and Figures in SAS for FDA submissionGood know of SAS, R and Sample size calculations softwareAbility to work independentlyAbility to travel 10%Preferred Qualifications:PhD in Statistics, Biostatistics or a related field with at least of 4 years of experience in medical device, biotech or pharmaceutical developmentMinimum of 2 years of management experienceExperience interacting with FDA and other regulatory agenciesStatistician with comprehensive experience in programming TLFs for regulatory submissionsExperience in supporting 510K, IDE, PMA, NDA, BLA, and or CTD submissionOther Requirements:Ability to regularly walk, sit, or stand as neededAbility to occasionally bend and push/pull as neededAbility to pass pre-employment drug screen and background check