Sr. Statistician - Medical Devices

Job ID: 622509 • • • Please Note: This is an onsite role in the Minneapolis area - we are only accepting candidates who are either local or plan to relocate to Minneapolis without monetary assistance • • • Summary: In this exciting role as a Senior Statistician, you will have primary focus responsibility to support innovative cardiovascular device clinical trials and contribute to efforts in the field of advanced analytics and data solutions. This group offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. See below for other details! Responsibilities: • Validates statistical analyses performed by other team statisticians (using R or SAS programming languages). • Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. • Uses sound statistical methodology to conduct studies relating to the life cycle of the product. • In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. • Develops and/or applies statistical theories, methods, and software. • Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. • Provides specifications and directions to the clinicians/statistical programmers. • Supports the regulatory review and approval of the experimental therapies. • May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Requirements: Master's Degree within Biostatistics (or similar) and 3+ years of experience working as a Statistician within Medical Devices or Drug Development Nice to Have (Preferred Qualifications): • Master's degree (or above) in statistics/biostatistics or relevant fields • 2+ years post graduate experience in medical research • Understanding of statistics and machine learning methods, ability to continue self-learning of technical and non-technical skills • Demonstrated proficiency in SAS, R or Python and experience with low level languages, including C/C++ • Prior experience in FDA and/or global regulatory submissions • Experience with adaptive designs, Bayesian modeling, sequential data, computational statistics • Experience in processing large data from various data sources • Experience in handling of protected patient health information • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR, CFR) • Insatiable desire to learn, to innovate, and to challenge themselves for the benefit of patients.