Naresh Kumar Reddy

Employment History

Sr.Stat.Prog.Specialist – March 2021 – Present

Perform data manipulation techniques and implement basic macro language to Covance, Bangalore, Karnataka /India. March 2021 – Present

facilitate listing and table generation and verification.

Analyze information and suggest solutions to programming and data analysis challenges  

Efficiently produce quality results under time constraints  

Interact effectively and cooperatively with other members of the department  

Successfully coordinate multiple priorities  

Develop, maintain, and produce statistical programs used in creating analysis datasets, tables, listings, and figures based on provided specifications (e.g., annotated CRF, derived dataset specifications, and statistical analysis plan)  

Develop and maintain documentation of analysis dataset, tables, listing, and figure verification  

Provide support and/or coordination of well-defined programming projects or portions of programming projects  

Ensure timely completion of assigned tasks by actively adapting and adjusting priorities  

Perform other duties as required by the Department 

Elite Alphametric Solutions Pvt Ltd ,Hyderabad ,Telangana /India – Statistical Programmer-2.August 2017 - February 2021.

Statistical Programmer-2 – April 2020 –February 2021

Involved in the Preparation of the of Documentation like Mapping Specs, CRF annotations.

Worked on the on SDTM Domains like DM, DS, AE, VS, LB, EX, CM etc. from Raw data following SDTM IG 3.2.

Good knowledge on SDTM mapping following 3.1.2/3.1.3/3.2 SDTM IG’s and also worked on the RELREC, Special purpose and other general observation classes.

Have experience in validation of SDTM datasets and running Pinnacle 21 to check compliance of SDTM domains and also involved in cleaning the report and also reported any issues with justification to report in SDRG.

Have experience knowledge and programming skills on the tables like safety tables (summary of demographics, disposition, AE summary tables) and have efficient skill on the creation of macros for the generation of the tables.

Engaged in creating analysis datasets and listing datasets as per specifications to meet regulatory and company standards.

Generated customized reports using the DATA _NULL _ and PROC REPORT techniques.

Extensively Used SAS/ODS for generating different output formats as requested.

Responsible for defining variables, merging datasets, creating derived datasets, data validation before processing.

Performed validation of SAS-generated output (tables, listings) via independent programming. Also performed QC checking and validation of SAS programs written by other programmers.

Performed data analysis and statistical analysis using SAS/Base, SAS Macro and SAS/SQL procedures.

Statistical Programmer – August 2017 – March 2020

Actively participated in Designing and Development of SAS Code.

Involved in SDTM mapping of DM, CM, EG, VS, MH, and AE domains according to SDTM standards.

Design the analysis datasets from the SDTMIG datasets by following the ADaM and SAP standards.

Cohort support for deriving Analysis datasets.

Involved in the development of tables like Demographic Data, Subject Exposure, Adverse Event, Medical History Tables etc.

Extensively used ODS functionality of SAS to create EXCEL, RTF, PDF reports.

Therapeutic Experience

Neuroscience - Neurology - Migraine (Phase I)

                               (Phase II)

Infectious Disease - Anti-Viral Therapy - Acute Hepatitis C virus (HCV) infection (Phase II)

Cardiovascular - Coronary Thrombosis (Phase I)

Cardio Metabolic - Type II Diabetes (Phase III)