Biostatistician II

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

The Biostatistician II  is responsible of providing biostatistics and data analytics expertise. The position will lead and actively take part in clinical trials design, programming and performing statistical analysis within Clinical Operations. The role is serving all organizational in vitro diagnostic device programs from end to end. This expert role will extend beyond Clinical Operations to R&D, Manufacturing and Regulatory Affairs/Quality Assurance as needed. The role will manage the Biostatistician 1 and or other members of the biostatistician team.

Key Duties

• Functions as a senior statistician on experimental strategies and design decisions for Clinical Operations, primarily provides statistical analysis leadership and guidance in the development of clinical research programs and in the design of individual studies.
• Provides ongoing guidance, mentoring and training with more junior biostatistician to ensure in-depth knowledge of the processes used and continued technical development.
• Works in collaboration with other Clinical Operations members on clinical trial design, such as statistical study design, sample size, statistical methodologies, randomization schemes and blinding procedures.
• Develops Statistical Analysis Plans (SAP) including statistical methodology, programming procedures, definition of derived variables, data handling rules and table/figure/graph/listing specifications and mock-ups.
• Applies or develops advanced programs, databases and tools resulting in best industry practice in data science.
• Leads and executes statistical analysis related to clinical trials.
• Reports the results to Clinical Project managers by developing study metrics and Statistical Analysis Report (SAR).
• Supports data management and data cleaning activities during the course and at the end of clinical trials.
• Manage statistical requests from other departments (R&D, RA/QA, others); performs statistical consultations, statistical analysis, or attributes other statistical resources to perform analysis if needed.
• Supervises biostatistical aspects of submissions to regulatory authorities; participates in presentations to regulatory authorities if needed. Develops and maintains close working relationships with other disciplines, particularly those that interact closely with biostatistics.
• Others related tasks if needed

Qualifications

• Bachelor's degree in statistics, biostatistics, or related field with 7-plus years of relevant work experience
• Master's degree in statistics, biostatistics, or related field with more than 5 years of relevant work experience
• Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.
• The work is performed with a computer, seated position most of the time.

Preferred Competencies:

• Strong technical writing, editing, and communication skills along with collaborative mindset. Ability to explain data science concepts to non-statisticians/data analysts.
• Advanced level of written and spoken English
• Deep understanding of FDA Guideline: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.
• In depth understanding of Good Clinical Practice (GCP).
• Deep knowledge of clinical trial data, and their analyses using both classical and modern methodologies
• Deep understanding of CLSI Guideline: Evaluation of Precision of Quantitative Measurement Procedures
• Extended experience in the development phases for IVD product and statistical analysis related to
• Excellent skills with SAS and/or R programming
• Excellent organizational skills with an ability to embrace changes and effectively manage multiple projects.
• Ability to present and explain statistical analysis principals.
• Ability to make statistical and data science decisions that have a lasting effect and significant impact on the success of the company.
• Demonstrates excellent problem-solving skills, a proactive approach, and the ability to make sound decisions on a regular basis and to communicate these clearly

Required international travel (Canada) 10%

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*