Shabbir B.

Unlock 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.

1) 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.

1) 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.

1) 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 challenges 4) Provide support and/or coordination of well-defined programming projects or portions of programming projects 5) Efficiently produce quality results under time constraints 6) Interact effectively and cooperatively with other members of the department 7) Successfully coordinate multiple priorities 8) Ensure timely completion of assigned tasks by actively adapting and adjusting priorities 9) 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.

•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.

1) SAS Programming in Back End Edit Check 2) Data transfer programming according to SDTM as well as CRDM CDISC standards 3) Creating Metadata specification as per CDISC standard and as per client request. 4) Data transfer Guideline 5) Non eCRF Guideline 6) Making Annotation of aCRF 7) 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

Well 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.

i have completed MBA in total quality management (TQM) from sikkim manipal distance learning education center.