Nirav Darji Email & Phone Number

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat, India

Amsterdam Area, Netherlands

Ahmedabad Area, India

Ahmedabad Area, India

o Development and Validation of Tables, Listings and Graphs as per the mock shells.o Development and Validation SDTM and ADaM datasets as per the specifications.o Development and Validation SDTM and ADaM datasets specification.o Development and validation of Derived datasets for Patient Profile.o Review of SAP.o Development and validation of Macros.

Ahmedabad Area, India

o Development and Validation of Tables, Listings and Graphs as per the mock shells.o Development and Validation SDTM and ADaM datasets as per the specifications provided.o Development and Validation of Edit Checks for data validation.o Review SDTM and ADaM datasets specification and provide inputs.o To review and provide inputs for eCRF.o Development and Validation of annotated CRF for SDTM.o Development and Validation of Define.xml.o Development and Validation of mock shells for Safety Tables and Listings.o Development of Macros.o Work as a Point of Contact for the programming team.o Managing work allocation for the entire team.o To make sure that team completes the assigned work in provided timelines.

Airoli, Navi Mumbai

o All management tasks related to team.o Make sure all the deliverable submitted within provided timelines and with high quility.o Creation of Tables and Listings as per the SAP and Mock shell provided.o Review Mock Shell and provide feedback.o Review Spec for SDTM and ADAM and provide feedback.o Creating SDTM and ADaM datasets as per the SPEC provided.o Create QC programs for Tables, Listings, SDTM and ADaM.o PEER review of the programs of team mates.o Update statistical macros as per the new requirement.o Validation of the statistical macros.o Work as a Study POC to communicate with Client.o Take part in study related calls\meeting.

Mumbai Area, India

o Creation of Tables and Listings as per the SAP and Mock shell provided.o Review Mock Shell and provide feedback.o Review Spec for SDTM and ADAM and provide feedback.o Creating SDTM and ADaM datasets as per the SPEC provided.o Create QC programs for Tables, Listings, SDTM and ADaM.o PEER review of the programs of team mates.o Update statistical macros as per the new requirement.o Validation of the statistical macros.o Work as a Study POC to communicate with Client.o Take part in study related calls\meeting.

Mumbai Area, India

- Working on SAS 8.2- Developing codes as per the Edit check description to generate the query reports which helps in Data cleaning.- Worked on projects related to Respiratory, Infectious Disease, Cardio Vascular, Oncology, Neuroscince.- PEER review of the codes developed by other programmers for Edit check.- Use annotated eCRF to develop the Edit checks.- Trained on InForm 4.6 tool to create the eCRF and to create the rules which prevents the wrong data entry in eCRF.- Successfully submitted all the projects on\before time.- Have suggested many process improvements.- Providing process training to the new joinee and also coaching\mentoring them until they become competent.

Providing Lectures on Bio Chemistry and Pharmaceutical Management.

Certification, Sas Programming

• Clinical SAS® Programming Projects: Importing the Data from various DBMS using SAS®/Access Edit Checks. Last Observation Carry Forward.

Masters In Pharmacy, Pharmacognocy

Activities and Societies: Worked on the project of Preclinical evaluation of Anti oxident effect of Herbal drug

M Pharma, Pharmacognosy