Senior Statistician - PVH

About the role

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.

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.
• 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.
• 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.

Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor's degree Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare

Qualifications

• Advanced degree with a minimum of 2 years of statistical experience in clinical trial design and data analysis within healthcare
• Nice to Have (Preferred Qualifications): 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)

Skills

• Statistical knowledge and experience to the design of clinical studies
• Ability to write or update 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)
• Knowledge of clinical trial methods and execution
• Data management expertise
• Windows environment and Microsoft Office Tools proficiency
• Effective communication skills

Benefits

Salary ranges for U.S (excl. PR) locations (USD):$118,400.00 - $177,600.00

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).

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.