Sarada Golla

Experience

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  Aldon Business Solutions, Inc

  Sept 2004 - Jul 2005

  SAS Consultant

  Developed statistical analyses programs, physician profiling and outcomes using SAS. Verified the overall system and validation documents, complete communication with necessary departments for clarifications, impact changes and modifications of the data. Developed test scripts to test the code’s intended functionality, check session log for proper executions and presence of errors and warnings. Created graphical representation to navigate through the specified hierarchy to support management decision-making and to explain the targeting strategies to the client.. Show less

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  InVentiv Health

  Jul 2005 - Sept 2005

  SAS Analyst

  Provided Programming, Systems and Statistical support to estimate carryover sales rates for Phase IV drugs. Involved in data analysis to understand the current segmentation and targeting methodology. Performed quality checks on the data to recognize inconsistencies and prepare the data for use in Statistical Analysis. Developed SAS programs to produce general linear models, regression models and other statistical models for predicting, forecasting trends and seasonal effects. Analyze each option and select the best targeting option. Show less

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  Pfizer Animal Health, Kalamazoo, MI

  Sept 2005 - Jan 2006

  SAS Developer

  Involved in extensive training to understand the Pfizer’s SOP’s-Standard Operating Procedures, which describes the department procedures for handling study data and records including reviewing, data entry, data verification and storage.

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  PPD

  Feb 2006 - Mar 2022

  • Exhibited exceptional leadership in understanding and implementation of vaccine trial guidelines documented under (CBER) and Office of Vaccines Research and Review (OVRR) document and developed a training for DTS vaccine members for regulatory submissions of EUA/BLA• Led the business and specification requirements for ‘Enhanced SDTM’ tool suite, on the new evolution of the Data Transformation Toolkit, SDTM and Define on Demand tools and procedures. Subject matter expert in CDISC SDTM implementation and Enhanced SDTM tool suite • Accounted for resolution of technical issues related to SAS, data collection platforms and the computational platforms used within the department Show less • Lead position contributing to process improvement efforts including the leadership of solution teams and authoring documentation on the Biostatistics and Programming departmental tools.• Key lead on global SAS environment and migration efforts into SAS Grid• Developed global macros under eCTD suite to support high quality regulatory submissions • Independently create, execute, maintain, and validate programs, utilities, tools, or software applications. • Present / teach at Department meetings, contribute to other general department documents or policies, and assist with Biostatistics web page development Show less • As a lead programmer worked on multiple projects that lead to the creation, execution, and maintenance of SAS programs, developing CDISC standard specifications for mapping SDTM Domains and ADaM datasets and actively contributed to process improvements and department initiatives, including the leadership of initiative solution teams• Generated Controlled terminology/code lists, Table of contents (TOC), Variable metadata, Variable value level metadata and annotated CRF. Developed global macro that supports eCTD submission standards • Programmed safety and efficacy outputs for NDA and DSUR submissions, involved in programming activities for ISS and ISE deliverables, assisted in the technical training and implementation of departmental procedures, tools, macros and policies within the Biostatistics department Show less • Ensured that SOPs were being followed and that appropriate project documentation was completed and maintained in an ongoing manner• Specified the general structure of the analysis database following industry guidelines, oversaw its development, and ensured completeness for use in all programming• Monitored staff assignments, evaluated, and shifted priorities and assignments to meet timelines and deliver high quality work. Supervised assigned staff by providing employee development, completed performance reviews, planning and documenting development and training Show less Involved in the data integration (ISS/ISE) of several studies under the same compound drug. Worked directly with project team leaders and client representatives to assess and develop project goals and timelines. Served as a project lead and oversee work of other programmers on team and ensure the validity of all the programs. Assumed leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed. Reviewed Annotated CRF, database, edit check specifications, data validation modules, mapping specifications and generated electronic submissions. Involved in data agreements with vendors, labs and client specifications Show less

  • Programming Manager, Center of Excellence DTS, Biostatistics and Programming

    Jan 2021 - Mar 2022

  • Programming Technical Manager

    Apr 2017 - Jan 2021

  • Principal Programmer Analyst

    Sept 2014 - Apr 2017

  • Programming Team Leader

    Apr 2014 - Sept 2014

  • Sr.Programmer Analyst

    Feb 2006 - Apr 2014
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  Thermo Fisher Scientific

  Mar 2022 - Nov 2022

  Senior Programming Manager, Center of Excellence DTS, Biostatistics and Programming

  • Senior level project oversight roles for studies, initiatives, tool development and working directly with project leads, development leads and client representatives to assess risks and issues related to project quality, timelines, and budgets• DTS LMT technology and process leader for internal deliverable tools including SDTM, BIMO/OSI, eCTD, Version Control, SAP Toolbox, Patient Data Dashboards and SAS environment setup

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  Vertex Pharmaceuticals

  Nov 2022 - now

  Associate Director Statistical Programming