POSITION:

Clinical Data Analyst

LOCATION:

Biovail Contract Research - Scarborough

POSITION DESCRIPTION:

Provide support in handling Study Database and Clinical Data, and generating tables and listings in the study report.

1. Develop Data Management requirements, including DMP, from protocols, CRFs, and other sponsor requirements.
2. Participate in meeting with external clients and provide high level of expertise for Clinical Data Management issues.
3. Setup, document, and validate the Study Database.
4. Implement and validate data controls (edit checks).
5. Provide support for coding (MedDRA, WHODRUG) auto coding, and AE reconciliation.
6. Provide support for importing Data from external source (LAB, eSource).
7. Produce listings and tables according to study protocols and data analysis plans.
8. Produce and verify SAS analysis datasets.
9. Provide input to standardized programming procedures.
10. Follow standardized programming procedures and SOPs.

QUALIFICATIONS & EXPERIENCE:

Bachelor of Science, Master of Science preferred.
Fields of studies: Health Sciences, Biostatistics, and Computer. Information Systems, and Computer Science.

2-3 years in a Pharma or in a CRO environment.
Previous experience in using EDC (eCRF).
Previous experience in MedDRA coding.
Previous experience in working with edit checks.

Good knowledge of GCP (Good Clinical Practices) .
Working knowledge of 21 CFR part 11 requirements and electronic submission (eCTD, SDTM).
Working knowledge of current ICH and FDA/TPD tables formats and statistical practice.
Ability to validate own work as well as that of others

Please forward your resume to: jobs@biovail.com

Biovail Contract Research is an equal opportunity employer. We thank all applicants for their interest; however only those selected for an interview will be contacted.