Sr Statistician - Exempt

Join our team in Mounds View, MN, where you will have the opportunity to work in a dynamic and innovative environment. In this exciting role, 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. You will support Cardiac Rhythm Management (CRM), Cardiac Ablation Solutions (CAS), Cardiovascular Diagnostics & Services (CDS), and Mechanical Circulatory Support (MCS).

A Day in the Life

Responsibilities may include the following and other duties may be assigned:

Validate statistical analyses performed by other team statisticians using R or SAS programming languages.

Design, plan, and execute biostatistical components of plans for research and development projects, establishing conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.

Use sound statistical methodology to conduct studies relating to the life cycle of the product.

Prepare the statistical component of protocols in development-phase projects, meeting project objectives, health authority guidelines, and clinical trial methodology standards.

Develop and/or apply statistical theories, methods, and software.

Summarize and interpret 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.

Provide specifications and directions to clinicians/statistical programmers.

Support the regulatory review and approval of experimental therapies.

Partner in trial design and establish standards for clinical conduct, and the collection, management, and/or reporting of data. Must Have (Minimum Requirements)

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) 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, innovate, and challenge themselves for the benefit of patients. Differentiating Factors

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas, or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching, and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.