Principal Statistician
Medtronic
Summary
Medtronic Clinical Research Solutions (MCRS) provides end-to-end clinical and scientific support services across Medtronic, enabling the execution of clinical studies and delivery of clinical statistical services that support evidence generation throughout the product lifecycle. This team partners with clinical, regulatory, data management, and statistical programming functions to generate high-quality clinical evidence that informs product development and regulatory submissions.
Job description
The Principal Statistician - MCRS supports clinical research studies through statistical design, analysis, interpretation, and reporting of clinical data. This role partners with cross-functional teams to develop statistical approaches for clinical investigations, contribute to study planning and execution, and deliver analyses that support product development and regulatory objectives.
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 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.
Minimum Requirements
- Bachelor's degree and 7+ years of statistical experience in clinical trial design and/or data analysis within healthcare (or advanced degree with 5+ years)
Nice to Have
- Bachelor's, Master's, or PhD degree in Biostatistics or Statistics
- 7+ years of statistics experience in the medical device industry, pharmaceutical industries, or clinical research organizations (CROs)
- 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, Bayesian methods, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, missing data strategies and multiple testing strategies
- Advanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package
- Participation in FDA 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
Requirements
- Bachelor's degree and 7+ years of statistical experience in clinical trial design and/or data analysis within healthcare (or advanced degree with 5+ years)
- Bachelor's, Master's, or PhD degree in Biostatistics or Statistics
- 7+ years of statistics experience in the medical device industry, pharmaceutical industries, or clinical research organizations (CROs)
- 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, Bayesian methods, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, missing data strategies and multiple testing strategies
- Advanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package
- Participation in FDA 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
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Incentive Plans
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.