Biostatistics - Clinical Data Architect

Req ID #:  192818
Location: 

Mattawan, MI, US, 49071

For 75 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 a Clinical Data Architect for our Biostatistics Team located in Mattawan, MI.

 

A Data Architect - Clinical Data Management is responsible for managing the clinical trial data for multiple assigned projects; confirming that the results of a clinical study are reported accurately, as specified in the applicable standards, and on-time. 

Qualifications

The following are minimum qualifications related to the Clinical Data Architect position:

  • Bachelor's degree with 3 or more years of relevant experience; contract research organization experience preferred.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Familiarity with drug development process.
  • Familiarity with effective clinical data management practices and regulatory compliance.
  • Familiarity with CDISC's, CDASH, SDTM, and Controlled Terminology standards.
  • Familiarity with different output formats (.xml, .xpt, sas7bdat, ASCII, text, .DAT, .xlsx) is a plus.
  • Demonstrates good organizational skills.
  • Ability to communicate verbally and in writing at all levels inside and outside the organization.

Competencies

Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.

Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 20,000 employees within 110 facilities in over 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. 


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 86% of the drugs approved by the FDA in 2021.


Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.


 
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com.


Nearest Major Market: Kalamazoo

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