Job Description

Sr. Statistician (12 month contract // REMOTE, team based in Mounds View, MN):

Candidate must be available on site 4 days per week in Mounds View, MN

Top 3 Skills:

1. Preferring an advanced degree in Statistics or Biostatistics
2. Coding experience with SAS, or secondarily with R
3. Familiarity with study or registry data (device data or pharmaceutical would be ideal)

Education Required: Advanced degree in Statistics or Biostatistics

Years’ of Experience Required: Advanced degree with a minimum of 2 years of statistical experience (e.g., statistical modeling, biostatistics)

Summary:

In this exciting role as a Senior Statistician, candidate will have primary focus responsibility to support innovative cardiovascular device and ablation device clinical trials and contribute to efforts in the field of advanced analytics and data solutions. The Senior Statistician will support Cardiac Rhythm Management (CRM), Cardiac Ablation Solutions (CAS), Cardiovascular Diagnostics & Services (CDS) and Mechanical Circulatory Support (MCS). The client’s Cardiac Rhythm Management Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. This role will support the design, analysis, and publication of clinical trial data.

Duties:

• 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.

Must Have:

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:

• 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.

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