Principal Statistician - PVH

About the role

The 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.

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.
• 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.

Requirements

To be considered for this role, the minimum requirements must be evident on your profile. 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

Qualifications

To be considered for this role, the minimum requirements must be evident on your profile. 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

Skills

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)

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, and Simple Steps (global well-being program).

Pay

$146,400.00 - $219,600.00

Schedule

Full-time