Pavan Binigeri

Experience

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  Infotech Systems

  Apr 2004 - Sept 2006

  • Module Developer

    Mar 2005 - Sept 2006

  • Trainee

    Apr 2004 - Feb 2005
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  Accenture

  Sept 2006 - Feb 2010

  Programming Analyst

  • Worked on EPDS/SAS tool for External vendor and inform Data sets.• Generate SDTM views of clinical data entered in eCRF’s to submit the data to FDA in appropriate format using CDISC submission data standards.• Generating Oracle SQL/PLSQL scripts that convert clinical data in to required format to load data in to CDR (Clinical Data Repository).• Access Clinical Trial Database using "EPDS" software tool & perform Data conversions according to specifications.• Define and develop SDTM mapping solutions per study requirements.• Define and develop standard productized SDTM diagrams.• Define and develop protocol specific productized SDTM diagrams. Show less

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  Parexel

  Feb 2010 - Dec 2010

  CLINICAL PROGRAMMER II

  • Worked on SAS & IMPACT tools for inform Data sets to build SDTM Data sets.• Generate SDTM views of clinical data entered in eCRF’s to submit the data to FDA in appropriate format using CDISC submission data standards.• Define and develop SDTM mapping solutions per study requirements.• Define and develop standard productized SDTM domains.• Define and develop protocol specific productized SDTM diagrams.

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  Accenture

  Feb 2011 - Jul 2015

  • Managing programming activities for multiple studies. • Successfully represent the department and the company in client meetings/presentations and maintain a positive working relationship with sponsors, collaborating associates, and vendor personnel • Lead and organize project programming teams, typically for multiple protocol or projects.• Creating ADaM datasets based on sponsor requirement, as well as based on Shells, and SAP and analysis performed.• Creating Adam Specs for the Adam Datasets based on the Mock shells & SAP.• Creating population indicator flags based on SAP.• Derivation of baseline flags based on SAP.• Creating Specification for JReview team for Early Medical Monitoring Analysis reports. Creating listings and tables based on sap/shell. Navigate to the J−Review tool and Perform QC the Reports in J−Review Tool as per the Spec was built. Show less

  • Assistant Operations Manager/Sr Scientific Programming Specialist

    Dec 2013 - Jul 2015

  • Sr Scientific Programming Analyst/Team lead

    Feb 2011 - Dec 2013
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  Labcorp

  Jul 2015 - Apr 2023

  • Monitors staff projects quality, timelines and budgets to foresee and correct issues and assure project expectations are met• Work closely with leads to ensure that staff resources are used efficiently, and team is well utilized• Manages resources within team: new hires, terminations, transfers, and contractors• Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures and administrative activities• Encourages staff career growth and development• Provides statistical programming support and technical support to team members• Act as Statistical Programming Project Manager for large global or other major programs which may include global responsibilities• Participates in internal and client audits, and regulatory inspections• Proactively lead, review and amend departmental processes and documentation• Facilitate advanced technical expertise, share knowledge at department meetings• Keeps abreast of new statistical programming practices, methods and tools, regulatory practices, and industry trends to stimulate departmental growth Show less • Supervision of statistical programmer within project activities• Statistical programming lead for large global or other major programs• Carry out line management for assigned staff, including Performance Management and Development activities, disciplinary procedures, and administrative activities.• Work with the Training specialists and other disciplines to ensure all members of the department receive training required to fulfill current role or to develop further.• Encourage an open and communicative two-way interaction with line reports.• Training and development of less experienced within the department.• Provide training on statistical programming related topics.• Contribute to review and amendment of department processes and supporting documentation• Facilitate the flow of information, comment and feedback between senior management and all levels of staff Show less • Coordinate programming activities for several clinical research projects • Serve as the statistical programming lead on internal project teams and coordinates programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures • Facilitate advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department • Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams • Ensure the efficiency, quality, and integrity of data reporting, and project activities executed Show less • Coordinate programming activities for several clinical research projects • Serve as the statistical programming lead on internal project teams and coordinates programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures • Facilitate advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department • Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams • Ensure the efficiency, quality, and integrity of data reporting, and project activities executed Show less

  • Senior Manager, FSPx Biometrics India

    Oct 2021 - Apr 2023

  • Manager, Statistical Programming

    Jan 2019 - Sept 2021

  • Manager Statistical Programming 0

    May 2016 - Jan 2019

  • Assistant Manager, Statistical Programming

    Jul 2015 - Apr 2016
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  Fortrea

  May 2023 - now

  Senior Manager, FSPx Biometrics India

  • Provide leadership and management to a team of statistical programmers.• Manage multiple statistical programming projects, ensuring adherence to timelines and budget.• Collaborate with cross-functional teams to develop programming plans and provide strategic input.• Ensure high-quality programming deliverables following regulatory guidelines.• Establish and enforce programming standards and quality control processes.• Stay up-to-date with emerging trends and advancements in statistical programming.• Mentor and guide junior programmers for their professional growth.• Effectively communicate complex programming concepts to non-technical stakeholders.• Support regulatory submissions by providing programming expertise.• Identify and implement process improvements for increased efficiency and quality. Show less