Senior Statistician - PVH

Medtronic • Mounds View, MN

3d • $118,400 - $177,600 • Remote

About The Position

This position is remote and will require 10% of travel. The role can be remote-based, located anywhere in the U.S. Preferred locations: Mounds View, MN. In this exciting role as a Senior Statistician, you will be responsible for statistical aspects of study design, study execution, and analysis of data from clinical studies conducted for regulatory approval or marketing purposes. This includes responsibility for design of studies, calculating of sample size and power, writing the statistical portions of protocols and statistical analysis plans, review of protocol and case report forms, analysis, including statistical programming, interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts. Work will generally be self-directed but will be reviewed by the manager at key time points.

Requirements

• Bachelor's degree
• Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare
• Advanced degree with a minimum of 2 years of statistical experience in clinical trial design and data analysis within healthcare

Nice To Haves

• Master’s degree or PHD degree in Biostatistics, or Statistics
• Experience as a biostatistician in clinical studies from the design through approval stages in the medical device or pharmaceutical industries
• Strong applied statistical skills, including survival analysis, regression modeling, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, Bayesian methods, missing data strategies and multiple testing strategies
• Experience writing or updating clinical reports/documents
• Advanced knowledge of and/or experience with statistical programming packages, including SAS and R
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR)
• High level of knowledge of clinical trial methods and execution
• High degree of expertise regarding research data management
• High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel)
• Demonstrated ability to communicate technical content to non-statisticians (written and verbal)

Responsibilities

• 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 medical device 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.
• 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.
• Partner in trial design and in establishing standards for clinical trial conduct, and the collection, management and/or reporting of data.
• Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be properly assessed. This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature.
• Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
• Identifies potential threats to study credibility, validity, and data integrity and works with study team to prevent, track, and manage potential problems.
• Writes the statistical analysis plan for the study.
• Performs statistical analysis using statistical programming software (e.g., SAS, R etc.).
• Validates and provides clear documentation of analysis programs.
• Writes Results and Methods sections of reports and manuscripts as needed and ensures interpretation of statistical and clinical findings in regulatory submissions, reports, and manuscripts accurately reflect the data collected.
• Consults with other (e.g., non-clinical) staff on statistical and analysis issues.
• Attends and contributes to project and department meetings.
• Demonstrates excellent collaboration and interpersonal skills.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior