Sr Statistician

Medtronic•Mounds View, MN

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Senior Statistician – Surgical In this exciting role as Senior Statistician, you will be responsible for statistical aspects of study design 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 of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and 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. A Day in the Life Responsibilities may include the following and other duties may be assigned. Designs, plans and executes biostatistical components of plans for clinical 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 and/or 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. Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met. This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature. Identifies potential threats to study credibility and validity, 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. 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.

Requirements

Bachelor’s degree with 4 years of statistics experience OR An advanced degree with 2 years of statistics experience

Nice To Haves

Master's degree or PhD in biostatistics or statistics
Experience in analysis of data from clinical studies and design of clinical trials
Strong applied statistical skills, including survival analysis, regression modeling, Bayesian methods, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, missing data strategies and multiple testing strategies.
Experience with adaptive designs
Advanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package.
Experience communicating complex statistical/machine learning results to technical and non-technical through journal publications, conferences, presentations/posters, and seminars
High level of knowledge of clinical trial methods and execution.
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR).
Prior experience in FDA and/or global regulatory submissions.
Demonstrated ability to communicate technical content to non-statisticians (written and verbal).
Demonstration of good oral and written communication skills
Well-developed interpersonal skills and collaborations with multiple functions
Demonstration or evidence of leadership competencies.
Strong attention to detail

Responsibilities

Designs, plans and executes biostatistical components of plans for clinical 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 and/or 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.
Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met.
This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature.
Identifies potential threats to study credibility and validity, 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.
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)