Jayesh Patel

About Jayesh Patel

Experienced SAS Certified programmer with several years of experience working in various clinical trials including analysis, reporting, macro development, testing and implementation of various projects for Pharmaceutical and CRO.• Experience in working on Phase II - IV of Clinical trials including Statistical Analysis. Good understanding of drug development process.• Familiarity with Medical dictionaries like MedDRA & WHODrug.• Good understanding of the Protocol, Annotated CRF, raw data, SDTM and Analysis datasets for all studies assigned.• Experience in SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/ODS & SAS/GRAPH in both UNIX and Windows environment.• Experience in development & validation of statistical TLFs, ad-hoc reporting patient profile listings and analysis data set programs of both Safety and Efficacy.• Good understanding of 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.• Experience in participating staff, data/operations, Clinical project team and study-level meetings for multiple projects.• Excellent interpersonal and communication skills, highly dedicated, quick starter, solution driven pattern programmer, Design and excellent at solving complex problems under strict deadlines.

Experience

1. Sr Sas Programmer

   Novartis

   Jan 2015 — Present

   Experience in generating SDTM data, writing specifications for ADaM and generating ADaM datasets following CDISC standards. Generated SDTM data for domains like AE, DM, VS, EX, CM, MH, LB• Experience in safety and efficacy statistical analysis of multiple therapeutic area studies. Perform data integrations for generating summary of safety and efficacy.•Generated safety summary table, descriptive tables, efficacy tables and created reports by using output like RTF, PDF and HTML.•Created SDTM datasets (version 3.2 ) for Lab, Adverse Events, and Demography from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.•Extensively used various procedures like proc means, proc univariate, proc freq, proc report, proc summary, proc gplot, proc sql etc•Proficient in indicating the input data sets, sorting and merging, transposing Techniques to get the required report.• Execute analyses specified in the Statistical Analysis Plan (SAP) under the guidance of the project statistician and other analysis supporting ad hoc requests.• Produce special reports to comply with regulatory requests. Use SAS ODS in combination with PROC Template to generate reports and use GTL, ODS and SG procedures for creating graphs.• Extensive work on CDISC ISS, integrating different study protocols for the analysis of drug effects on subjects.• Program datasets in SDTM and ADaM data formats following the CDISC data standards.• Extensively worked on creating Population, Adverse Events, and Concomitant Medication data sets.• Created Tables, Listings and Graphs as per the tables, listings and Graph shells provided by the lead statistician and involved in validation for TLGs.• Involved in developing specification for data sets based on STDM and ADaM standards.• QC of Analysis datasets programmed by other programmers by parallel programming using raw data.

Education

• New Jersey Institute of Technology

  Master's degree

  2006 — 2008