Executive, Pharmacokinetic-arpl-bp Ar

About Apotex Inc. 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. 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 inhouse 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 , Validation and review of SDTM, ADaM, and • Creating data sets, tables, listings and Procedural comparison, sorting of source data.