Biostatistics Analysist - Eurofins Viracor, LLC

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

Basic Function and Scope of Responsibility:

The Biostatistics Analyst is primarily responsible for applied statistics in support of clinical data analysis plus new assay/method, design and validation efforts for product development.

Essential Job Duties:

Biostatistics Analyst - Minimum

• Provide biostatistical support for R&D projects requiring statistical analysis of clinical data, and programming and handling omics data.
• Work closely and effectively with Bioinformatics & BioPharma leadership to ensure that R&D projects are progressing, and milestones are achieved pursuant to organization and/or client timelines
• Communicate effectively with both internal and external clients regarding technical issues/projects
• Write verification/validation reports and SOPs in accordance with Viracor Eurofins' established guidelines
• Serve as team member on various ongoing and future new test idea generation projects
• Develop and maintain an effective working relationship with clinical laboratory team to allow effective, coordinated assay transition from the R&D phase to clinical use
• Develop an effective working relationship with Regulatory Affairs/Quality Assurance to assure R&D laboratory is in compliance with Viracor Eurofins' established guidelines for documentation, quality and safety
• When appropriate, conduct regular individual meetings with R&D Scientists that focus on biostatistical requirements related their respective responsibilities and project priorities
• Communicate program objectives to cross-functional teams (clinical laboratory, regulatory teams)
• Commitment to a high quality of work and at the same a high level of productivity
• Maintain current knowledge of advances in pertinent fields, through attending lectures, seminar, professional conferences and courses
• Regularly contribute to laboratory team meetings that focus on associate training, associate development and continuous improvement in laboratory processes
• Preparation of poster presentations for national scientific meetings
• Prepare manuscripts for publication in peer reviewed journals
• Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times
• Active participation in team and company meeting
• Other duties as assigned by management
• Complete Media Lab and other assigned departmental training
• Performance Expectations:
• Develop and maintain an effective/professional working relationship with external customers and internal colleagues to provide the best service possible
• Represent department and organization professionally and favorably and in accordance with established Company standards and associate attributes at all times
• Other duties as assigned by management

Senior Biostatistics Analyst - Fully meets the responsibilities of Biostatistics Analyst plus the following:

• Leading the Biostatistical analysis and R&D efforts to analyze the clinical data.
• Actively support our Pharma clients and participate in the study design

Qualifications