Principal Statistician - PVH

Job Overview

Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant. Journée type Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life‑enhancing therapies. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross‑functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects. The preferred location for this role is Mounds View, MN.

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.
• Oversight of statistical support and deliverables for ensuring adherence to study specific requirements as well as consistent applications of relevant methods across the portfolio.
• In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Research, develop and/or applies novel 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.
• 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.
• Takes a leadership role in responding to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regulatory agencies regarding study design and interpretation.
• Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies, including more advanced methods.
• Methods must be appropriate for the kind of data collected and required assumptions must be tested.
• 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.
• Lead development for process improvements and standardization for the department and the statistics group.
• Attends and contributes to project and department meetings.
• Demonstrates excellent collaboration and interpersonal skills.

Minimum Requirements

• Bachelor's degree
• Minimum of 7 years of statistical experience in clinical trial design and data analysis within healthcare
• Advanced degree with a minimum of 5 years of statistical experience in clinical trial design and data analysis within healthcare

Preferred Qualifications

• Master’s degree or PhD degree in Biostatistics, or Statistics and minimum 8 years of statistics experience within medical device industry or pharmaceutical industries
• 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
• Advanced knowledge of and/or experience with statistical programming packages, including SAS and R
• Participation in FDA, PMDA or other regulatory meetings, especially panel preparation and presentation
• 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)
• Experience writing or updating clinical reports/documents
• Pour les diplômes de baccalauréat obtenus en dehors des États-Unis, un diplôme qui satisfait aux exigences de la réglementation 8 C.F.R. § 214.2 (h) (4) (iii) (A) est requis.

Salary and Benefits

Salary ranges for U.S (excl. PR) locations (USD):$146,400.00 - $219,600.00. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

• 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)

• Regular employees are those who are not temporary, such as interns.
• Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.
• Please note some of the above benefits may not apply to workers in Puerto Rico.

Authorisation de Travail et Parrainage

Chez Medtronic, nous nous engageons à favoriser un environnement dans lequel les employés peuvent s'épanouir et avoir un impact significatif. Conformément à notre approche de planification de la main‑d’œuvre à l'échelle de l'entreprise, le parrainage d'autorisation de travail aux États-Unis (H‑1B, TN, J, etc.) est proposé exclusivement pour les postes de niveau Principal et supérieur, où l'expertise spécialisée s'aligne sur les besoins métier à long terme. Les postes en dessous du niveau Principal exigent que les candidats possèdent une autorisation de travail américaine sans restriction au moment de l'embauche et pour la durée de l'emploi.

Égalité, Diversité et Inclusion

La politique de Medtronic consiste à assurer l’équité en matière d’emploi (EEO) à toutes les personnes, indépendamment de l’âge, de la couleur de peau, de la nationalité, du statut de citoyenneté, d’un handicap physique ou mental, de la race, de la religion, des croyances, du genre, du sexe, de l’orientation sexuelle, de l’identité et/ou expression de genre, des informations génétiques, de l’état matrimonial, du statut au regard de l’assistance publique, du statut d’ancien combattant ou de toute autre caractéristique protégée par la loi nationale, fédérale ou locale. En outre, Medtronic proposera des aménagements raisonnables aux personnes qualifiées ayant un handicap. Chez Medtronic, la plupart des postes sont publiés sur notre site dédié aux offres d’emploi pendant 3 à 7 jours.