As the Founder and CEO of Oryxion, I’m Shabbir Bookseller, a seasoned professional with over 13 years of experience in CDISC standards and statistical programming. I specialize in driving transformative projects and delivering exceptional results in the healthcare industry. My passion for innovation and deep understanding of therapeutic areas such as oncology, gastrointestinal, and respiratory, position me to advance drug discovery and enhance patient well-being.At Oryxion, my mission is to provide unparalleled service to our clients. I lead a dedicated team of experts to deliver high-quality, compliant, and innovative solutions tailored to meet the unique needs of each project. My role as CEO involves setting the strategic direction of the company, ensuring seamless execution of complex projects, and maintaining the highest standards of excellence.Clients benefit from my extensive technical background in SAS programming, which includes expertise in CDISC SDTM & ADaM standards, Define.XML creation, and comprehensive dataset validation. I excel in transforming raw data into meaningful insights, ensuring accuracy and integrity, and supporting successful drug submissions. My strategic management skills enable me to drive efficiency, manage resources effectively, and achieve exceptional results.With a proven track record of leading successful drug submission processes, I bring a wealth of knowledge and experience to every project. My ability to build and lead high-performing teams, combined with my commitment to mentoring the next generation of programmers, ensures that our clients receive not only cutting-edge solutions but also consistent and reliable support.At Oryxion, we understand the challenges and complexities of the healthcare industry. Our goal is to partner with our clients to drive innovation, enhance patient outcomes, and deliver results that exceed expectations. Connect with me to discover how we can collaborate to achieve your clinical research and data analysis goals.
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Founder, CeoOryxion Jun 2023 - PresentBengaluru, Karnataka, IndiaUnlock the full potential of your clinical research endeavors with Oryxion. We are a dynamic and innovative company specializing in statistical programming, biostatistics, clinical data management, and medical writing. Our comprehensive services cater to both the Full-Service Provider (FSP) model and In-house teams, ensuring exceptional support tailored to your specific needs. -
Founder/CeoAxial The Data Analytics Oct 2020 - PresentBengaluru Urban, Karnataka, India -
Associate Manager, Statistical Programming, BiometricsQuartesian Jan 2020 - Oct 2020Bengaluru Area, India -
Team Lead, Statistical Programming, BiometricsQuartesian Jan 2018 - Dec 2019Bengaluru Area, India1) Responsible for contributing to specific project objectives and team deliverable.2) Review statistical analysis plan and provide comments.3) Review annotated case report form and provides comments to data manager.4) Review data values in the raw datasets and provide comments to biostatistician/data manager.5) Responsible for all statistical programming activities including self validation checklists.6) Perform role of validation programmer for all assigned studies.7) Ensure all tabulation/analysis datasets are compliant with CDISC/client standard. -
Senior Statistical ProgrammerQuartesian Jul 2016 - Dec 2017Bangalore1) Contribute to project specific objectives and team deliverable.2) Provide periodic training to subordinates and assign the work.3) Responsible for initiation of protocol and SAP discussion.4) Review statistical analysis plan and provide comments.5) Review annotated case report form and provides comments to data manager.6) Review data values in the raw data sets and provide comments to bio-statistician/data manager.7) Responsible for all statistical programming activities including self validation checklists.8) Perform role of production and validation programmer for all assigned studies.9) Responsible for creation of define/specification for tabulation and analysis data sets.10) Ensure all tabulation/analysis data sets are compliant with CDISC/client standard.11) Ensure all programs are compliant with the SOP's and project specific guidelines. -
Statistical Programmer/AnalystTheorem (Now Chiltern) Clinical Research Jul 2015 - Jun 2016Bengaluru Area, India1) QC'ing SDTM and AdaM datasets.2) Creating Specification for SDTM (Metadata) and ADaM Dataset based on client requirement as per CDISC Standard.3) Analyze information and suggest solutions to programming and data analysis challenges4) Provide support and/or coordination of well-defined programming projects or portions of programming projects5) Efficiently produce quality results under time constraints6) Interact effectively and cooperatively with other members of the department7) Successfully coordinate multiple priorities8) Ensure timely completion of assigned tasks by actively adapting and adjusting priorities9) To Interact with client to understand their requirement and to discuss project related time line.10) Create and/or annotate and review tables and listings mocks; ensure internal consistency within and among tables and listings; ensure that all CRF fields are displayed on listings. -
Programmer, Biometrics (Biostatistics).Theorem Clinical Research Oct 2012 - Jun 2015Bangalore•Generating SDTM and AdaM datasets.•Creating Specification for SDTM (Metadata) and ADaM Dataset based on client requirement as per CDISC Standard.•Co-coordinating with QC teams for large projects which include delegation of QC work.•Program routine data displays, such as data listings, in accordance with approved statistical analysis plan and shell displays for clinical research studies.•Create and maintain standard QC documentation.•To Interact with Clinical Data Management (CDM) to resolve data issues.•Create and/or annotate and review tabels and listings mocks; ensure internal consistency within and among tables and listings; ensure that all CRF fields are displayed on listings. -
Associate Programmer,CdpQuintiles Research Pvt.Ltd.Bangalore Mar 2011 - Oct 2012Bangalore1) SAS Programming in Back End Edit Check2) Data transfer programming according to SDTM as well as CRDM CDISC standards3) Creating Metadata specification as per CDISC standard and as per client request.4) Data transfer Guideline5) Non eCRF Guideline6) Making Annotation of aCRF7) Perform thorough QC/Validation of own and other programmers work.8) Support senior members for creating standard macro’s in maintaining efficient interfaces with internal and external customers.9) Creating macros whenever required to make the task simpler and easier
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Trainee AtEpoch Research Institute (Sas Accredited Training Center) Jul 2010 - Feb 2011Well versed with DATA _NULL_, SAS® Formats, Informats, Functions, DATA Manipulation and Report.Clinical SAS® Programming Projects:Importing the Data from various DBMS using SAS®/Access, Edit Checks, Last Observation Carry Forward, Creation of Listing and Table for Datasets.Activity:Creation of Listing and Table for DM, VS, PE, DS, LB, AE Datasets, Created Dummy Datasets of DM, VS, LB, AE, PC, & PP as per the CDISC SDTM 3.2 for the dummy Protocol. Creation of Listing and Table for DM, VS, LB & AE Datasets as per the Dummy Mock Shell Tables and Listings for Dummy Protocol.
Shabbir B. Education Details
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Total Quality Management -
Allana College Of Pharmacy,Pune UniversityB.Pharmacy
Frequently Asked Questions about Shabbir B.
What company does Shabbir B. work for?
Shabbir B. works for Oryxion
What is Shabbir B.'s role at the current company?
Shabbir B.'s current role is Principal Statistical Programmer, Founder/CEO.
What schools did Shabbir B. attend?
Shabbir B. attended Sikkim Manipal University - Distance Education, Allana College Of Pharmacy,pune University.
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Shabbir Patanwala, CSM, CBAP, PMP, B.Engg
Manager Business Analysis At Td Bank Group, 2020 League Of Excellence RecipientMississauga, On
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