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.