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Click here or scroll down to respond to this candidateCandidate's Name
Email: EMAIL AVAILABLE Address: Street Address Mobile: PHONE NUMBER AVAILABLESUMMARY OF QUALIFICATIONSExperienced SAS Programmer/Analyst focused on pharmaceutical development across multiple therapeutic areas, including supporting submissions to the FDA.Created Analysis Datasets, Tabulation Datasets and Listing Datasets as specified in SAP using SAS Data Step, Functions and Procedures. Responsible for SAS programming for producing reports, Summaries, Listings, Graphs using Proc Report.Experience in writing specifications for SDTM and ADaM datasets, Tables, Listings and Figures to be used in the report generation.Experience in data analysis and report generation for Phases I III of clinical trials including data validation, safety updates, and safety and efficacy summaries to support CSR generation and eventual submission.Strong experience in producing SDTM and ADAM domains in accordance with CDISC standards.Experience in forecasting hours and updating internal Revenue and Recognition Log for the studies to keep track of the outputs delivered and provide input to the Project Management Team on a monthly basis.Lead multiple studies in creating delivery trackers, assigning work to the team, setting up expectations for a delivery and communicating the timelines.Experience in working as a technical Liaison in a multicultural global environment including India, Europe and Canada.Ability to work either individually with minimal supervision or as a member of a large team and can handle multiple projects completing the tasks as scheduled with high quality and on time.Experience in working with internal and external clients to understand the expectations, requirements for deliverables and communicating the same to the team members.Experience in creating SDTM/ADaM Define.xml, Analysis Data Reviewer's Guide (ADRG), Clinical Study Data Reviewers Guide (cSDRG), transport files to be included in Define.xml package.Proficient expertise in manipulating and analyzing various data types related to clinical trials.Excellent written and verbal communication skills. Able to communicate complex quantitative ideas clearly.Experience in dual-programming both as production/QC programmer.Decisive with strong leadership skills and flexible in work schedules.PROFESSIONAL EXPERIENCEIQVIA Mar 18 Dec 23Statistical Programmer II /Study Lead, Statistical ProgrammingWorked as a Programming Team Lead for Phase I Sickle Cell Disease study on both production and QC side to create TLFs before moving to PTL role.Worked as Lead for Epilepsy (Opus) and SFN(Convey) studies in October, 2019. Responsible for communicating with client on required updates to the deliverables.Update specifications according to the required updates and review the updated outputs after the team makes changes and confirm if the changes are according to client requirements.Responsible for SAS programming for producing reports, Summaries, Listings, Graphs using Proc Report. Creating RTF, PDF and HTML listings, tables and reports using SAS ODS.Day to Day tasks include programming datasets, creating tables and listings, transferring new data over and running production tasks for existing programs. Involved in writing and updating Specifications for new/existing outputs.Responsible to deliver the outputs on time to the client and follow internal process to file the outputs delivered to the client, creating backup and update team specific internal tracker to keep informed of the delivery status.Created Analysis Datasets, Tabulation Datasets and Listing Datasets as specified in SAP using SAS Data Step, Functions and Procedures.QC programmer using Gen tools and Standard QC macros for creation and validation of SDTM, AdaM datasets as well as TLFs.Support management of study timelines and budgets while ensuring adequate resources.Continued to be part of standards committees and lead initiatives to improve function and efficiency of the department.CLINICAL TRIAL EXPERIENCE:Study Phase:Phase 2Indication:Diabetic NeuropathyRole:Lead Statistical programmerKey Responsibilities:Worked as a Lead Statistical Programmer for Convey. Responsibilities include communicating with client regarding updates needed on the deliverables, implementing the requested changes by communicating within team. Update specifications for outputs according to the requested changes and review the programmed/updated outputs to confirm the changes made.Negotiate timelines for deliverables with client in case of any roadblocks and proactively communicate the status of our assignments both within the team and with the client. Post Delivery, worked on creating snapshot, updating internal programming tracker.Study Phase:Phase 2Indication:EpilepsyRole:Lead Statistical ProgrammerKey Responsibilities:Took over as Statistical Team Lead for OPUS. Responsibilities include communicating with client regarding changes needed on the deliverables, implementing the requested changes by communicating within team.Update specifications for outputs according to the requested changes and review the programmed/updated outputs to confirm the changes made.Proactively managed the deliveries without delay in timelines thru efficient communication with internal and external stakeholders.Delivery experience includes creating snapshot, updating internal programming tracker, loading outputs via SharePoint and sending delivery notification email to the recipient team.Study Phase:Phase 2Indication:Spinal muscular atrophy# of Countries:7# of Sites:15Role:Statistical ProgrammerKey Responsibilities:Provided SAS programming support to clinical study group for clinical trial projects.Collaborated with other SAS programmers in code validation, data validation and results validation.Developed SAS Macro codes for data manipulation, data analysis, statistical analysis and routine report generation.Transformed and derived new variables as per protocol or Statistical Analysis Plan (SAP).Created Analysis Datasets, Tabulation Datasets and Listing Datasets as specified in SAP using SAS Data Step, Functions and Procedures.Study Phase:Phase 2Indication:Parkinson's DiseaseRole:Statistical ProgrammerKey Responsibilities:Provided SAS programming support to clinical study group for clinical trial projects.Collaborated with other SAS programmers in code validation, data validation and results validation.Developed SAS Macro codes for data manipulation, data analysis, statistical analysis and routine report generation.Transformed and derived new variables as per protocol or Statistical Analysis Plan (SAP).Created Analysis Datasets, Tabulation Datasets and Listing Datasets as specified in SAP using SAS Data Step, Functions and Procedures. Worked on Tables, Listings and Figures delivered quarterly for Cross Functional Data review.THERAPEUTIC AREASTherapeutic AreaExperience (Roles)NeurologyParkinson's DiseaseProduction ProgrammerSeizure Disorderproduction programmer/Study LeadDiabetic Neuropathic Painproduction programmer/Study LeadEpilepsyExtensively used SAS/ODS procedures to develop HTML, RTF and PDF Reports Develop SAS programs to check data quality in analysis datasets and automated scripts to check data stability. Performed Data Validation and Data Cleaning on Clinical Trial Data. Develop SAS macro codes for data manipulation data analysis, statistical analysis and routine report generation. Transformed and derived new variables as per programming specifications.GastrointestinalConstipationQC programmer using Standard Qc macros for creation and validation of SDTM, ADaM datasets as well as TLFs.EDUCATIONBachelor of Sciences, Mathematics/Statistics, Physics and Electronics.S.V.University, IndiaLICENSES AND CERTIFICATIONSCertified Base SAS Programmer, 2014Certified Advanced SAS Programmer, 2015Certified ISTQB Foundation Level Tester, 2013REFERENCES:Available upon request. |
