Summary
Overview
Work History
Education
Skills
Certification
Languages
Websites
References
Timeline
Generic

Veera Manesh Bheemala

AUBREY,TX

Summary

Certified Statistical Programmer with around 8 years of experience in Pharmaceutical and biotech industries.

Self-motivated Senior Statistical Programmer successfully managing multiple, concurrent projects on consistent basis. Experienced in developing TLF's for submissions. Innovative professional willing to work hard to drive business success.

Expertise in preparing Tables, Listings and Graphs (TLG's) using Base SAS, SAS/Graph, SAS/SQL, Macros and SAS/ODS according to Statistical Analysis Plan (SAP).

Exposure in implementing CDISC SDTM and ADaM standards.

Provide SAS programming support on phase I-IV clinical trials.

Experience in Individual as well as Integration projects.

Experience in handling / working on multiple projects and studies.

Expertise in statistical SAS procedures like FREQ, UNIVARIATE, MEANS, SUMMARY reporting procedures like REPORT, PRINT.

Good understanding of drug development process.

Excellent command in producing reports employing various SAS procedures and DATA _NULL_.

Emphasis on adhering to organization standards (SOPs), Statistical Analysis Plan (SAP), documentation, recycling macros and producing reusable macro library. Integrated Summary of Safety (ISS) using CDISC Standards (SDTM).

Exposure to ICH, GCP and MedDRA coding dictionaries.

Excellent command in producing reports employing various SAS procedures. Expertise in developing SAS programs for data cleaning, analysis, and reporting of clinical data, including complex data manipulation and creating customized listings/reports of clinical data.

Excellent record of fast-track career growth and expanding skill-set, handling increasing levels of responsibilities.

Coordinate the randomization, IRT and unblinding activities for clinical protocols, including interacting with statisticians, clinical staff, drug supply management and IRT vendors to assure the correct randomization is followed.

Develop independently randomization and IRT strategies for a program by coordinating specification implementation with vendor.

Experience Integrating data across multiple studies.

Excellent organizational, interpersonal, and communication skills.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Senior Statistical Programmer

ThermoFisher Scientific
TX
06.2022 - 11.2023
  • Involved in statistical analysis production and validation programming tasks
  • Working on Phase II Oncology Therapeutic for the client Moderna, etc., Have good experience on Narrative task
  • Working on Intext tables
  • Involved in programming of safety, efficacy tables and listings for reporting
  • Validating SDTM transfers biweekly and making sure that the cutoff dates are accurate
  • Created listings from the raw data to submit them to the medical team
  • Involved in reviewing and performing spot checks on datasets, tables, Listings and figures
  • Good command on Internal Applications which manage the request lifecycle, Specification documents and TFL Shells.

SAS Programmer/Analyst

Biogen Through Icon Plc and Intone Networks
Irving, TX
06.2020 - 06.2022
  • Working on Phase II and III of Ophthalmology therapeutic area
  • Working on multiple studies in parallel to support the needs on the Priority basis
  • Generate and validate ADaM datasets, summary tables, data listings and graphs for analyses of study data using SAS standard coding practices
  • Comparing Rave data with current data by aligning it to Rave format as per the code List Mapping and generating the listings with differences and submitting to DM team
  • Worked on OE dataset which is a new addition in SDTM IG 3.3
  • Created and validated SDTM, ADaM datasets and TFL's following the requirement to meet the timelines
  • Make sure shells are aligned with requirements mentioned in SAP
  • Created listing from raw datasets
  • Performed spot check on specification document to ensure it is correct based on the SAP and Protocol
  • Created SDTM datasets with data from different sources
  • Validated TFL's that are already developed and Validated at Vendor side and logged the issues to bring up
  • Worked on multiple imputated data
  • Interacting with other members of the Biostatistics & Statistical Programming team and with other groups, such as Data Management to ensure a high level of client satisfaction and successful execution of projects
  • Supported in creation of integrated summary of safety (ISS) and Integrated summary of efficacy (ISE) reports
  • Worked on legacy and pooled studies, thus by combining clinical data of different protocols of the same clinical project
  • Performed edit checks to find invalid data or data entry issues in the raw data
  • Collaborated with the lead statistician on generating/finalizing analysis specs
  • Used Output Delivery System (ODS) facility to write custom ISS and ISE reports directing SAS output to RTF and HTML files
  • Provided Quality Control (QC) programming support by developing programs for comparing them with source programmer's code
  • Expertise in Integration (Pooling) of datasets from different studies for further analysis.

SAS Programmer/Analyst

BMS / Celgene Through Icon Plc and Intone Networks
Irving, TX
05.2019 - 06.2020
  • Co-leaded Phase II and Phase III Oncology legacy studies
  • Responsible for CRF annotations, creating and reviewing specification document for SDTM and ADAM as per CDISC standards, following protocol, SAP and Shells
  • Provide programming support for the creation/maintenance of programs used for data entry, data management, data validation, statistical report generation (tables, listings, patient profiles) on numerous contracts for various clients and studies
  • Handling Ad-Hoc requests that come up from the Marketing and statistical team
  • Providing updated data to the team through kiteworks when requested applying data cutoffs
  • Ensure TMF is setup by CPA and maintained
  • Perform quarterly audits of regular documents
  • Extensively worked on Safety and Efficacy tables
  • Documented quality control of safety and efficacy tables, listings and graphs as defined in the SAP
  • Creating derived data from the post-process data and make it available to the vendor team
  • Involved in meeting with the biostatisticians and team leads in understanding the Case Report Forms (CRF's)
  • Worked closely with Data Management to assure data quality by providing ADHOC analysis
  • Updating patient profiles every month and make them available to the entire team through the sFTP Site and SharePoint
  • Involved in developing utility macro that outputs pooled ADAM datasets from extract data to perform analysis on COVID19 cases
  • Responsible to perform pinnacle21 checks as well as edit checks to identify any data issues and report them to data management team
  • Reviewing the outputs and doing the spot checks for the clinical data
  • Experience working on Global macros
  • Created study specific reusable macros in creating and Validating datasets and TFL's
  • Well versed with coding dictionaries such as MedDRA and WHO drug.

SAS Programmer/Analyst

Novartis / Alcon Laboratories Through Icon Plc
Fort Worth, TX
03.2016 - 04.2019
  • Understanding data in the field of Ophthalmology
  • Experience on early development Phase I studies
  • Analyzed different phase clinical trials and their designs including single blinded, double blinded, randomized, parallel and crossover through SAS programming
  • Generate and validate ADaM datasets, summary tables, data listings and graphs for analyses of study data using SAS standard coding practices
  • Created Summary Reports and Tabular Reports using Proc Report and Proc Tabulate
  • Generated output files in different formats like rtf, pdf and excel formats using SAS ODS
  • Extensively worked on Safety and Efficacy tables
  • Good working experience in SDD and GPS environments
  • Migrated studies from PC SAS environment to the SAS Drug Development (SDD) and also from SDD to GPS to manage and share accurate clinical research information to make informed clinical decisions
  • Extensively used PROC MEANS, PROC FREQ and PROC UNIVARIATE to create outputs based on SAP and shells for statistical analysis of clinical trial data
  • Involved in CTT meetings
  • Contribute to efforts related to project- level activities
  • Create testing scripts to verifying functional requirements for global reporting macros which are executed in SAS Drug Development
  • Advisory capacity for technical challenges
  • Analyze existing processes and replaced them with more efficient processes
  • Ensure SAS programs adhere to SOPs, guidelines, and specifications
  • Cross-validated programs with others: compared outputs and proofread the coding
  • Perform ADHOC programming per regulatory and statistician requests
  • Maintain quality and timeliness of all deliverables of the projects
  • Met timelines & communicated issues to the lead statistician effectively and proactively.

Education

Master of Science - Chemistry

Southern Illinois University Edwardsville
Edwardsville, IL
08.2015

Master of Science - Biochemistry

GITAM University
04.2011

Bachelors in Biotechnology -

Andhra University
01.2009

Skills

  • SAS: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/ODS, CDISC, PC SAS, SAS EG, Pinnacle 21
  • Office Tools: MS-Office
  • Specialties: CDISC, SDTM, ADaM, ISS, ISE

Certification

  • Certified Clinical Trials Programmer Using SAS 9
  • Certified Base Programmer for SAS9

Languages

English
Professional
Telugu
Professional

References

References available upon request.

Timeline

Senior Statistical Programmer

ThermoFisher Scientific
06.2022 - 11.2023

SAS Programmer/Analyst

Biogen Through Icon Plc and Intone Networks
06.2020 - 06.2022

SAS Programmer/Analyst

BMS / Celgene Through Icon Plc and Intone Networks
05.2019 - 06.2020

SAS Programmer/Analyst

Novartis / Alcon Laboratories Through Icon Plc
03.2016 - 04.2019

Master of Science - Chemistry

Southern Illinois University Edwardsville

Master of Science - Biochemistry

GITAM University

Bachelors in Biotechnology -

Andhra University

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Veera Manesh Bheemala