Biostatistics Analysist - Eurofins USA Clinical Diagnostics

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.

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

Essential Knowledge, Skills and Abilities:

Biostatistics Analyst - Minimum

• MS degree (or Ph.D.) in Biostatistics, Public Health, Bioinformatics
• Expertise in the use of frequentist statistics, laboratory validation data and power analysis.
• Understanding of linear, generalized linear, and mixed regression model methodology
• Strong programming skills in languages such as R, Python, C and C++, and ability to work in Linux..
• Experience of working with Next generation sequencing data is highly desirable
• Published records to represent above skills
• Problem solver
• Strong management skills
• Demonstrated proven experience in managing complex projects, ability to succeed even with challenging projects, appreciation of priorities and critical factors.
• Substantial technical writing: protocols, study reports, regulatory communications and manuscripts
• An innovative and prepared mind to identify and protect unique intellectual properties is a bonus
• Commitment to and track record of high quality of work
• Ability to establish and maintain effective working relationships with other groups
• Goal oriented, with excellent time management and organizational skills
• Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
• Excellent verbal & written communication skills
• Keenly attentive to detail
• Ability to keep sensitive information confidential

Senior Biostatistics Analyst – Fully meets the qualifications of Biostatistics Analyst plus the following:

• MS/PhD At least 3 years of relevant experience.
• BS At least 7 years of relevant experience

Physical Requirements:

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
• Ability to continuously operate a personal computer for extended periods of time (4 or more hours)
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions

The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Eurofins Viracor LLC is an equal opportunity employer and encourages individuals from all backgrounds to apply. By submitting your application, you acknowledge and agree to the following conditions:

1. Drug Screen: Successful candidates will be required to pass a standard drug screen as part of the pre-employment process.
2. Background Check: A thorough background check will be conducted for all potential employees. This may include, but is not limited to, criminal history, education verification, and employment history.
3. Visa Sponsorship: Eurofins Viracor LLC does not sponsor employment visas. All candidates must have the legal right to work in Lenexa, KS without requiring sponsorship. Unless approved by HR and supporting parties.

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.