Senior Statistician

Title: Sr Statistician Location: Mounds View, MN/Hybrid- 4 Days Onsite, Local, MN - Should be Physically Present- & Ready to visit the site as needed. Duration: 12 months + (possibility of extension) Shift: Standard shift HM's Top Needs: • A degree in statistics or biostatistics • Coding experience with SAS or R • Familiarity with study or registry data (device data or pharmaceutical would be ideal) Years’ Experience Required: • Bachelor's degree with a minimum of 4 years of statistical experience (e.g., statistical modeling, biostatistics) OR • Advanced degree with a minimum of 2 years of statistical experience (e.g., statistical modeling, biostatistics) Job Description: • 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 experimental therapies. • May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Nice to Have (Preferred Qualifications): • Master's degree (or above) in statistics/biostatistics or relevant fields • 2+ years post graduate experience in medical research • Advanced degree • – MS 2+yrs statistics analysis with Bonus of with direct experience on with the design and/or analysis of clinical trial data. • 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.