RAI RAI

Norristown, Pennsylvania ***** 610-***-****

ad1q0n@r.postjobfree.com https://www.linkedin.com/in/rai-rai-3281114/

ARIAL (LM)

MARKET READY

SUMMARY

An experienced and highly insightful senior SAS programmer and statistician with a strong background in data analysis, CSR writing, reporting and documentation, data manipulation, and categorical analysis. Creates and validates SDTM / ADAM specifications, domains, and datasets while generating complex ad-hoc reports utilizing raw data. Emphasizes phase one to four working experience with clinical trial data in the pharmaceutical and biotech industries, with a keen focus on CRO environments. Develops SAS programs and specs for analysis datasets, patient profiles, tables, listings, and graphs. Fosters and manages quality output and deliverables in adherence with challenging timelines.

Macro Development Project Management SAS Coding

Statistical Method Development Exploratory Analysis Query Creation

Validations Oversight Safety Tables Studies Management Files Development

TECHNICAL SKILLS

SAS Modules: SAS Version 9.4, 9.3, 9.2, SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/SGPLOT, SAS/STAT, SAS/ACCESS, SAS/REPORT, SAS/SQL, SAS/ODS., on UNIX

Operating Systems: UNIX, MS-DOS, PC Workstations, Windows, XWINDOWS, MS NT and XP.

Databases: MS Access, Oracle, Oracle Clinical, MS Excel, Medidata Rave

Other: UNIX LINUX Reflection X Advantage, SAS Studios and SAS Enterprise Guide

EXPERIENCE

ARBUTUS BIOPHARMA, WARMINSTER PA

Sr. Associate SAS Programmer Aug 2022-Nov 2023

Developed CDISC SDTM / ADAM specs. Reviewed and validated CRO deliverables.

Worked on production and validation programs, for tables, listings, and figures and SDTM / ADAM datasets.

Worked on to create Mock Shells.

Contributed in writing SAP

Therapeutic areas Hapatitis.

Jauuary 2021- July 2022: Because of COVID19 I did not work. Protected from PANDEMIC.

PFIZER PHARMACEUTICALS, Remote, Collegeville, PA

Senior Statistical Programmer, 2018-2020

Developed CDISC SDTM / ADAM specs. Reviewed and validated CRO deliverables.

Wrote SAS programs to QC and validate CDISC SDTM domains of Legacy data created by outsourced companies.

Worked on Pinnacle 21 Enterprise to check CDISC compliance of SDTM and ADAM datasets.

Worked on production and validation programs, for tables, listings, and figures and SDTM / ADAM datasets.

Supervised programming activities outsourced to oversees companies in India and China.

Received excellent training on CDARS, SAS Studios, UNIX LINUX, SDTM / ADAM, and writing specs.

Served in therapeutic areas if osteoarthritis pain study and epidemiology study on virus.

WIND TREE THERAPEUTICS (DISCOVERY LAB), Warrington, Pennsylvania

Senior Biostatistician (Contract), 2016-2017

Wrote SAS programs to generate mock shells for tables, listings, and figures,

Imported Transport files (ADAM /SDTM) to SAS datasets as well as raw data from iMEDNet EDC and Medidata Rave.

Reviewed and validated safety, efficacy, and baseline CDISC SDTM domains.

Imported and exported raw data from various databases (Inform, Clintrial, iMednet EDC ).

Contributed to generation of ADAM specs and datasets.

Generated all summary tables, listings, and graphs from SDTM / ADAM datasets.

Generated efficacy tables through Logistic Regression, Poisson Regression, Proc Genmod, CMH, Proc GLM, Survival Analysis-Proc Lifetest (Comparing Time to Event), Kaplan Meier Plot, and Capturing Hazard Function by PHREG .

Worked in therapeutic area of respiratory distress syndrome.

PRINCETON PHARMATECH, Princeton, New Jersey

Clinical SAS and Statistical Programmer, 2016

Helped generate TLG programs and outputs.

Generated safety, efficacy, and baseline CDISC SDTM domains and validated and quality-controlled project-related SDTM domains. Developed ADaM Specs and SAS programs to generate ADaM datasets.

Contributed to metadata, domain specs, controlled terminology, protocol, eCRF and SAP to generate SDTM domains and ADaM datasets .

Participated in therapeutic areas of skin disease with patch.

BAYER PHARMACEUTICALS, Whippany, New Jersey

Senior Clinical SAS and Statistical Programmer (Remote), 2014-2016

Wrote SAS codes to generate safety, efficacy, and baseline CDISC SDTM domains and validate and quality-controlled project-related SDTM domains. Worked to generate TLG programs and outputs.

Contributed to metadata, domain specs, controlled terminology, protocol, eCRF and SAP to generate SDTM domains and ADaM datasets .

Generated and validated oncology domains TU, TR, and RS on RECIST criteria.

Co-created ADAM datasets of RECIST, including ADTTE, ADTR, ADPFS with ADSL, ADLB, ADVS, ADCM, and ADMH.

Generated summary tables, listings, and Kaplan Meier Survival Plots. Worked in developing and creating summary statistics from Proc LIFETEST and captured hazard functions from Proc PHREG

ADDITIONAL EXPERIENCE

COVANCE, INC. (CRO), Princeton, New Jersey, Senior Statistical Programmer, 2013. Developed and supported statistical programming computer systems used in production of statistical analysis plan (SAP)-planned tables, data listings, and graphs as well as integrated summaries of safety and efficacy, ad hoc analyses, and electronic submission deliverables, including datasets, data documentation, programs, programming table of contents, and patient profiles . Generated and validated safety, efficacy, and baseline ADaM datasets and generated and validated TFL. Wrote patient profile and edit check programs. Converted SAS data to multi-sheet MS excel as well as different file formats (Excel, CSV, and Plain Text Files) to SAS datasets.

MERCK RESEARCH LAB, Upper Gwynedd, Pennsylvania, Contract Statistician and Senior Scientific Analyst, 2013. Provided programming support to scientists in department of pharmacogenomics and biorepository biospecimen management systems and future biologic research in updating BBMS databases . Worked to extract, manipulate, summarize, and analyze data from different databases and capture DNA / specimen variables from various SDTM domains (i.e., dm, ds, mh, cm, lb, vs, pc, pp, pd, mh) and ADaM datasets. Created CSV / EXCEL files and load them into BBMS database. Migrated array of legacy variables to CDISC SDTM standard before each loaded into database. Imported and exported data from various databases .

CYTEL, INC. Boston, Massachusetts, CDISC Programmer and SAS Programmer (Contract and Remote), 2012. Generated SDTM domains per CDISC standards for Legacy study. Reviewed annotated SDTM CRF and created mapping specifications from source CRF data to meet CDISC SDTM standards / sponsor standard. Created database specifications and metadata specifications for SDTM and ADaM data models. Worked with other team members to ensure outputs proved correct and complete. Contributed to producing CDISC SDTM domains for phase one, two, and three studies. Checked SDTM compliance through OPENCDISC VALIDATOR. Converted different file formats (Excel, CSV, and Plain Text Files) to SAS datasets. Produced and validated TLGs.

SYMBIANCE, INC. (CRO), Princeton, New Jersey, Senior Statistical Programmer, 2011. Produced and validated tables, listings, figures, and CDISC SDTM and ADaM datasets. Wrote SAS codes to convert raw datasets to CDISC SDTM Version 3.1.1 and 3.1.2 on mapping specifications provided by client. Drove conversion of safety-related data to CDISC SDTM, including writing specifications for ADaM data and generating tables, listings, and graphs . Contributed to analysis of pain medication project, and epilepsy project. Developed all SAS codes to generate efficacy tables, safety tables, and background tables. Validated outputs generated by other programmers. Produced elegant graphs in pain medication and PK parameters .

TAKE SOLUTIONS (CRO), Princeton, New Jersey, SAS Programmer (Contract), 2010-2011. Led data building for CDISC SDTM and ADAM datasets . Wrote and developed SAS codes to convert raw datasets to CDISC SDTM Version 3.1.1 and 3.1.2 on mapping specifications provided by stakeholders .

ICON CLINICAL RESEARCH (CRO), North Wales, Pennsylvania, Biostatistician (Contract), 2009-2010. Acted as part of breast cancer project team working to analyze data on RECIST criteria. Contributed to generating mock shells, tables, listings, and graphs. Managed quality control and peer review of summary tables, listings, and graphs. Wrote standard macros. Maintained global macro library. Ensured quality, implementation, and timeliness of standards and deliverables. Wrote data specifications and SAS programs to generate ADaM data sets and TLF. Created analysis data for Solid Tumors with RECIST criteria. Managed endpoints to include Overall survival, objective response rate and progression free survival, and KM plot .

JOHNSON & JOHNSON (ORTHO CLINICAL DIAGNOSTICS), Raritan, New Jersey, Statistical Programmer (Contract), 2008-2009. Developed statistical analysis plan and extracted and built SAS data sets for analysis. Designed, coded, and implemented SAS reports (tables, listings, graphs) for diagnostic trials using SAS / STAT, SAS / BASE, SAS / GRAPH, and ODS on SAS 9.1 and SAS 9.2. Managed estimation of variance components, sensitivity, and specificity analyses. Calculated confidence intervals for sensitivity and specificity as well as cutoff analysis of signal to cutoff (S/C) ratio . Led distribution of S/C ratios . Generated scatter and histogram plots and summary statistics, comparing mean difference and paired t test .

CLINPRO, INC., Bound Brook, New Jersey, Statistical Programmer (Contract), 2007-2008. Designed, coded, and implemented SAS reports (tables, listings, and graphs). Created and modified existing SAS programs and macros for data and reports. Assisted with FDA submissions of ISE and ISS with extensive graphs, tables, and listings. Led validation of TLF and analysis data . Worked in therapeutic areas of oncology, cardiovascular, diabetics studies, and blood pressure reductions.

AUXILIUM PHARMACEUTICAL, INC., Malvern, Pennsylvania, Statistical Programmer (Contract), 2007. Contributed to project by developing new macros and modifying old macros from to efficiently streamline process of data extraction to final delivery. Built PK analysis data set for AUC, Tmax, Cmax, and Cmin . Produced summary tables (summary statistics, including mean, std., geometric mean, p-values and 95% confidence intervals), listings, and figures. Managed and worked in therapeutic areas of testosterone (urology and endocrinologists) across phase one to four .

BRISTOL-MYERS SQUIBB, Hopewell, New Jersey, Statistical Programmer (Contract), 2006. Built and validated safety, efficacy, and baseline datasets per specifications and wrote SAS codes and macros while using validated Macros for generating TLFs . Participated in development and review of study-specific procedures, case report forms, dataset requests, and other study documents. Supported other departmental initiatives. Worked in therapeutic areas of CV and metabolics.

OCTAGON RESEARCH SOLUTIONS, INC. (ACCENTURE), King of Prussia, PA Senior Statistical Programmer Contract, 2003-2006. Created mock shells from CRF, SAP, and Protocols. Wrote SAS codes and macros for efficacy, safety, and baseline tables, listings, and graphs. Designed, wrote, and validated SAS programs for derived datasets, tables, listings, and graphs. Validated cancer projects outputs and KM plots with tables and listings. Served in therapeutic area of CNS (depression), pain medication, oncology, and fertility drugs.

MERCK RESEARCH LABS, Rahway, New Jersey, Senior Statistical Programmer, 2002-2003. Oversaw biostatistics and statistical programming, Completed several electronic submission programs. Wrote SAS code to build derived datasets, tables, listings, and figures. Worked in therapeutic area of Vioxx (rheumatoid and osteoporosis arthritis and post-operative pain).

PURDUE PHARMA LP, Princeton, New Jersey, SAS Programmer (Contract), 2001-2002. Generated derived data sets and tables for demographic, primary efficacy, secondary efficacy, treatment emergent adverse events, vital signs, labs, and shift tables. Managed primary efficacy analysis (Kaplan-Meier, Cox Proportional Hazard, and ANOVA) and secondary efficacy analysis (withdrawal effects: Kaplan-Meier, Cox, and ANOVA / ANCOVA / Repeated Measures) as well as summary tables, listings, and SAS graphs.

FIRST USA BANK, Wilmington, Delaware, Contract SAS Programmer and Statistician, 1999-2001.

JANSSEN RESEARCH FOUNDATION, Titusville, New Jersey, Contract SAS Programmer and Statistician, 1998-1999.

MERCK RESEARCH LAB / SMITH HANLEY, Blue Bell, Pennsylvania, Contract SAS Programmer and Statistician, 1997-1998.

AMGEN INC., Thousand Oaks, California, Contract SAS Programmer and Statistician, 1996-1997.

EDUCATION

MISSISSIPPI STATE UNIVERSITY, Starkville, Mississippi

Ph.D., Applied Statistics Masters of Statistics

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