Jiten Patel

Background

About Jiten Patel

Over 10+ years of professional experience as PK-PD/Biostatistician and Programmer for various Phases I to IV Clinical Trials in multiple therapeutic areas such as Oncology, Diabetes, Cardiovascular, Urology, organ transplantation, Parkinsons’s disease, obesity, osteoporosis and Immunology. • Expertise in PK analysis including study design, preclinical to clinical consideration utilizing information from pre-clinical TK studies also PK/PD Modeling, Simulation, Compartment PK, SAD-MAD study, BA-BE study, DDI study and population PK. • Comprehensive knowledge of applied statistical methodologies. • Create SAS programs to generate or validate Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards datasets as per the study specifications. • Sound knowledge of clinical drug development process and regulatory guidelines such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and ICH guidelines. • Exposure in various SAS/STAT modelling procedures used for the statistical modelling of the clinical/statistical endpoints. • Writing scientific rationale for the complicated study designs (i.e. with respect to the selection of type of study i.e. cross-over, replicate, partial replicate with reference scaling, use of truncated AUC, etc; about selection of analytical assay i.e. chiral or achiral; with respect to the selection of biological matrix i.e. blood, plasma, serum or urine etc; about the moiety to be analyzed i.e. parent or metabolite; with respect to the need of baseline corrections; etc.) • CDASH compliant, Annotation / Mapping of CRF, Validation / QC of the data integrity, Developing SDTM Mapping Specification, Pre-SDTM module, Transport –define.XML. Develop code executing program when running interacting mode.