Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, creative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
Executive - Pharmacokinetics responsible to implement CDISC standards in compliance with the regulatory requirement and managing all key activities of data management, software development and validations. Perform pharmacokinetics and statistical analysis of concentration – time data and to generate the randomization schemes, as and when required.
Job Responsibilities
- Creating SDTM and ADaM datasets for the studies conducted by Apotex using CDISC standards
- Annotation of CRFs for the clinical studies conducted by Apotex.
- Development and validate of in-house SAS programs in line with the quality standards and regulations.
- Ensuring the validation of software’s are done in line with the applicable company quality standards and regulations
- Validation and review of clinical trial data.
- Creation of Specifications for Define.xml, Validation and review of SDTM, ADaM, and Define.xml.
- Creating data sets, tables, listings and Procedural comparison, sorting of source data.
- Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable
- Prepare justification for queries from regulatory agencies and tracking of regulatory deficiencies
- Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance wi