Send Analyst - Biostatistics

Charles River Mattawan , MI 49071

Posted 3 months ago

SEND Analyst

  • Biostatistics

Req ID #: 48132


Mattawan, MI, US

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

Job Summary

We are seeking SEND Analysts for our Safety Assessment site located at Mattawan.

The SEND Analyst is an integral part of a global team engaged in producing CDISC compliant SEND data sets. Responsible for acquisition of study data from data sources and processing of data through specialized software. Responsible for the preparation of specific domains and/or for the preparation of Define and/or shipment of SEND deliverables to the client. Responsible for developing and executing plans for creation of specific domains and/or Define file creation and/or shipment of SEND deliverables in accordance with User Guides, and industry regulatory guidelines (SENDIG); provide relevant nSDRG (Nonclinical Study Data Reviewer's Guide) content and/or Define file and/or shipping documentation to ensure accuracy. Correlate SEND domains to ensure alignment with the study report and/or correlate the Define file to SEND dataset content and/or correlate shipping requirements with shipping documentation.

The following are minimum requirement related to the SEND Analyst position.

  • Create specific SEND domains and/or Define file in adherence with CDISC standards and/or ship SEND deliverables in adherence with requirements.

  • Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports; and understand CDISC controlled terminology, if applicable.

  • Ensure work is compliant with applicable guidelines and regulations (e.g., CDISC)

  • Use independent judgement to provide solutions to inconsistencies between SEND data sets and study documentation or to escalate to management in a timely manner.

  • Provide nSDRG content on specific SEND domains, if applicable

  • Consistently deliver high-quality services and regular project status/updates to management.

  • Informs management of any issues that may potentially impact quality and/or on time delivery of SEND data.

  • Maintaining an in-depth understanding of evolving CDISC SEND standards and other regulatory standards/guidance.

  • Education: Bachelor's degree (B.A./B.S.) or equivalent experience in a scientific or related discipline.

  • Experience: 2 to 3 years related experience in a scientific environment. An equivalent combo of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer

  • M/F/Disabled/Vet


Nearest Major Market: Kalamazoo

Job Segment: Toxicology, Biotech, Pharmaceutical, Laboratory, Science, Research

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