• Several years of Sr. SAS programming knowledge in the CRO and Pharmaceutical sectors.• Clinical trial expertise in numerous therapeutic applications such as CNS, Oncology, and Pulmonary Medicine (Phases I to III).• CDISC standards were used to map the SDTM and ADaM standards.• Proficiency in processing, interpreting, and reporting clinical trial data, as well as knowledge of the drug development life cycle.• Experienced in Neurology, Respiratory, Urology, Vaccines, Immunology, CNS, Endocrinology, Oncology, and other therapeutic areas.• Interpretation of the Case Report Form (CRF) in compliance with FDA/CDISC or sponsor standards.• Skilled in utilizing SDTM IG, ADaMIG, and SAP to build and validate SDTM and ADaM datasets according to CDISC criteria.• Utilizing SAS/ODS, developed HTML, RTF, and PDF reports and developed SAS graphs employing methods such as PROC SGPLOT and PROC SG Panel.• Created SAS macros with debugging tools to simplify routine processes and improve quality and productivity.• Used raw data to create complicated ad-hoc reports.• Created specifications for analyzing datasets in compliance with company guidelines• verified conformity of SDTM and ADaM datasets by Pinnacle 21 tool,• Followed FDA instructions to create an electronic submission package (define.xml or define.pdf).• Aided Biostatistics and Data Management teams with SAS.• Using SAS procedures such as PROC SGPLOT and PROC SG Panel, generated SAS graphs and HTML, RTF, and PDF reports.• Proc Life test, Proc Phreg experience in survival analysis for oncology trials to evaluate endpoints such as Overall Survival (OS), Progression-Free Survival (PFS), Time to Progression (TTP), and Overall Response Rate (ORR).• Solid Tumor Response Evaluation (RECIST v1.1) Criteria Experience.• Thorough understanding of clinical trial materials such as the protocol, SAP, annotated CRFs, PSUR, and DSUR.• Capable of managing several projects. • Ability to program in SAS on a variety of platforms and operating systems (Windows and Unix).• Superior problem-solving and analytical capabilities.• Ability to operate in a team atmosphere with clinical team members.• Excellent attention to detail and accuracy.Technical Skills:• SAS: SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/REPORT, SAS/STAT, SAS Enterprise guide• Operating Systems: Windows 98/2000/XP/NT/7, MS-DOS, Sun Solaris-UNIX• Database: Oracle Clinical, Clin–Trial and MS Access, SQL• Office Tools: MS Office, MS Vision• Programming Languages: SAS, C, C++, Visual Basic, SQL, PL/SQL
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Sr. Sas ProgrammerConfidential Sep 2021 - Present• Creating and Verifying Oncology SDTM Domains like TU, TR, and RS. • Establish and Validate ADaM domains such as ADTTE and ADRs. • Follow FDA/CDISC or sponsor requirements while completing the Annotated Case Report Form (acrf.pdf). • Using SDTM IG, ADaMIG, and SAP to develop and validate SDTM and ADaM datasets according to CDISC criteria. • Using SAP, develop and validate safety and efficacy tables, listing them according to Mock Shells.• Creating and maintaining requests for ad-hoc reports. • Communicating with clients on a frequent basis to share status updates, corrections, or recommendations. • Carry out all of the following responsibilities in accordance with the Quality Management System's or the corresponding client’s (standard)'s operating procedures (SOPs). • Verified with stats for any revisions to the statistical analysis strategy, mock-ups/shells/templates, etc.• Ensured that the team's quality control document was valid and up to date. Validation was executed according to the QC monitoring sheet's instructions. • Created the template's safety, effectiveness, and outputs, and validated them using the QC tracking sheet. • Established programs by using debugging options such as MPRINT, MLOGIC, and SYMBOLGEN to define macro parameters. • Contributed to the development of define.xml and assisted in the establishment of the reviewer's guide (SDRG, ADRG). • Assisting in the development of ISS and ISE datasets and tables, as well as Listings. • Worked with PROC SGPLOT and PROC SG Panel to create various graphs. • Assisted statisticians, data managers, and medical writers in developing reports using SAS programming.• Analyzed and evaluated clinical data for completeness, correctness, and consistency.• Developed SAS macros as well as other facilities to help SAS programmers get things done faster. • TLGs for Oncology Efficacy Analysis, sensitivity analysis, survival analysis, and other data analysis as needed by the research. -
Senior Statistical ProgrammerIndependent Contractor Dec 2018 - Sep 2021• Providing programming assistance for the creation of integrated reports, post-submission activities, submissions • Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP), and departmental rules were followed to generate tables, lists, and graphs. • Involved in CRF Annotation to guarantee that all needed data is eventually gathered. • Advanced SAS abilities, such as Macros and SQL procedures, are used to create compact and versatile code. • Programs for analyzing datasets that have been produced independently • For raw and analytic datasets, CDISC SDTM and ADaM standards were followed. • As a secondary programmer, I was responsible for validating SAS algorithms that generate derived-analysis datasets and data analyses. • Aided in the development of ISS and ISE datasets and tables.• Participate in the establishment of standard operating procedures (SOPs) for data reconciliation, programming standards, and software validation. • Running the Pinnacle21 tool and understanding the reports are your responsibilities.• By creating Last-Observation-Carried-Forward (LOCF) data, I worked on dropouts and missing data. • On programming and validation duties, I collaborated with statisticians and support programmers. • Implemented QA and QC validation for deliverables in accordance with departmental SOPs. • Participated in the development of analytical plans. • Using PROC GLM and PROC ANOVA, I worked on regression analysis and correlation research.• For incorporation in integrated clinical statistics reports and comparative reports, required programs and process data displays are swiftly produced, documented, and tested. • Contribute to the integrated clinical/statistical report and other related studies.• Confirming that analytical data and programming code meet regulatory and industry criteria and are structured uniformly for effective programming and analysis. -
Statistical ProgrammerIndependent Contractor Oct 2016 - Dec 2018• Developed shells for examining data sets, tables, figures, and listings (TFLs). • Respond to information requests from clients (ad hoc data listings, standardized report templates) • Expertise in developing and verifying SDTM, ADaM datasets, tables, lists, and graphs in accordance with authorized specifications in conjunction with the team to generate and assess scientific reports for correctness and clarity. • Using SAS methods based on the mapping requirements, converted current raw data into standard CDISC SDTM / ADaM domain datasets that met all CDISC criteria. • Create transport files from SDTM data to evaluate using Open-CDISC Validator, as well as a Reviewers Guide that addresses the faults and warnings that were created. • I assisted in the creation of OSI and e-sub deliverables in accordance with CTD guidelines. • Provided SAS programming to statisticians and clinical data administrators in order to analyze the clinical trial and produce results. • Support regulatory submissions with statistical programming for integrated synopsis of safety and efficacy (ISS and ISE). • Developed edit check tools to identify data inconsistencies in raw datasets given by the data management team. • Created SAS programs for data cleaning, validation, analysis, and report production, as well as complicated and reusable macros and substantial usage of existing macros. • Conducted Open CDISC validation and fixed Open CDISC Validator's concerns.• SAS ODS was used to generate reports in RTF, PDF, and HTML formats. • Querying, joining tables, creating, and managing tables were all done with SAS tools like Proc SQL. • Ensured that ad-hoc reports were delivered correctly and on time as needed. • Contributed to the development, debugging, and validation of project-specific SAS programs that generated SAS datasets, summary tables, and data listings in accordance with departmental guidelines.
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Statistical ProgrammerIndependent Contractor Feb 2014 - Oct 2016• Primary programmer for preparing Clinical Study Reports (CSR), mostly tables, listings, and graphs, and ensuring that all deliverables satisfy business standards and requirements while adhering to internal norms. • Providing SAS programming inputs in clinical trial data analysis and report generation as a bridge between statisticians and clinical data management. • Assisted in the creation and validation of SDTM, ADaM Datasets, and TLGs in accordance with SAP and authorized requirements. • Procedures such as PROC LOGISTIC, PROC REG, PROC ANOVA, PROC MIXED, and others might be used to generate the efficacy report in collaboration with the statistician. • Using various sorts of methods, created sophisticated tables and graphs, and validated the tables. • Used PROC SGPANEL and SGPLOT to create figures, mostly Quality tailored graphics. • Independent programming was used to verify SAS-generated outputs (TLGs). • PROC SQL is used to build and join tables. • Programs that have been micritized to generate reports that can be used in the future.• Created RTF and PDF reports using SAS ODS output statements.• Maintained quality checks to ensure timely submission of standard programming deliverables.
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VICTOR ΛDΞTIBΛ CSP-SM, CSPO, CAL-E,O,T, PSM I, PSM II, PSPO, SPCT6, SSM, SA, PMP, ICP-ACC/ATF
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