SUMMARY

• Certified SAS professional wif 8 years of experience in Analyzing and Reporting of Clinical Data wif extensive knowledge of CDISC standards implementation in various Pharmaceutical and CRO Industries.
• Clinical experience includes extensive knowledge and experience of clinical phases me - IV in a different therapeutic areas such as Oncology, Rheumatoid Arthritis, Cardiovascular Diseases, and Anti-Depressants molecules. Well versed wif different study design like Single Blind, Double Blind, Triple Blind, Placebo, and Randomized.
• Knowledge of teh Drug Development Process in phase me, II and III of clinical trial data.
• Experience in preparation of SAS datasets, Tables, Listings, Graphs, Reports, Output Delivery System (ODS) and Summaries according to requirements, Specifications, Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP).
• Good knowledge on ICH, NDA, IND, FDA-21 CFR part 11and GCP regulations and guidelines.
• Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
• Extensive experience in creating SDTM and Analysis Datasets using SAP and CDISC Standards.
• Experience in Data mapping from none CDISC SDTM to SDTM and data mapping from SDTM to ADaM standards.
• Proficient in handling various clinical trial domains like Adverse Events (AE), Laboratory tests (LB), Exposure (EX), Vital Signs (VS) and Disposition (DS) etc.
• Exceptional ability in problem solving, data analysis, complex reports generation wif macro and data transfer between different environments
• Generated Integrated Summaries of Safety (ISS) and Efficacy (ISE) from individual studies as per teh Specifications
• Experience in validating CDISC SDTM Domains using Proc CDISC Procedure.
• Experience working wif Pharmacokinetics and Pharmacodynamics property of teh drug.
• Experienced in using various SAS modules such as SAS/BASE, SAS/STAT, SAS/ODS, SAS/GRAPH and SAS/MACROS.
• Extensively used SAS Procedures and Functions to produce Tables, Listings, Graphs (TLGs)
• Experienced in generating Ad-Hoc Reports based on Client Requests.
• Knowledge of CRF- Annotation wif respect to various database designs.
• Experience in Data Manipulation procedures such as SAS Formats/Informats, Merge, Proc Append, Proc Datasets, Proc Sort and Proc Transpose.
• Having excellent command in producing reports employing various SAS procedures like Proc Print, Proc Report, Proc Tabulate, Proc Mean, Proc Freq, Proc Univariate, Proc Transpose, and Data NULL
• Familiar wif standard Dictionaries such as MEDRA and WHODRUG
• Performed Edit check programming to identify potential data issues and conducted data validations as per data dictionary guidelines.
• Used SAS Macros extensively in teh creation of new programs as well as teh modification of existing programs to improve ease and consistency of results.
• Involved in file transport as part of Case Report Tabulation (CRT) for regulatory submissions.
• Highly self-motivated and goal-oriented professional to work individually in a team environment.
• An excellent problem-solver, able to quickly grasp complex systems and identify opportunities for improvements and resolution of critical issues.

TECHNICAL SKILLS

SAS Skills: SAS/BASE, SAS/EBI, SAS/MACRO, SAS/SQL, SAS/MCL, SAS/IMP, SAS/WRS, SAS/EM, SAS/EG, SAS/STAT, SAS/ACCESS, SAS/CONNECT, SAS/ODS, SAS/SHARE, SAS/STAT, SAS/ETL, SAS/GRAPH.

Operating Systems: Windows 98/2000/NT/XP, Vista, MS-DOS, UNIX, Sun Solaris, IBM Mainframe

Languages: C/ C++, SAS, PL/SQL, VB, HTML

Database: Oracle Clinical, MS-Access, DB2, SQL Server

Tools: MS Word, MS Excel, MS Power Point, MS Project, WinSCP

PROFESSIONAL EXPERIENCE

Confidential, King of Prussia, PA

Sr. SAS Clinical Programmer

Responsibilities:

• Actively involved in analyzing teh Phase II and Phase III clinical studies data, prepared analysis datasets, and generated Tables, Listings and Graphs as per teh Statistical Analysis Plan (SAP).
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Generated Tables, Graphs and Listings for inclusion in Clinical study reports and regulatory submission;
• Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Modified macros for report generation using SAS Macros as per teh statistician’s requirements.
• Developed efficacy and safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
• Validated most of teh SDTM and ADaM domains as per CDISC standards by using specifications and ran OCV (Open CDISC validator) to know teh SDTMs generated as per CDISC standards or not.
• Involved in handling missing results following various imputations like LOCF, BOCF and WOCF etc.
• Converted teh analyzed datasets into transport (.XPT) and data definition documents (DDD) files for e-submission to FDA.
• Used SAS ODS to generate TFLs as per shell. Imputed missing dates for analysis data in ADAE, ADCM and ADMH.
• Prepared mapping specifications of raw datasets to CDISC SDTM Standards. Developed programs from teh scratch and also modified/updated existing programs.
• Handled dropouts and missing data by using traditional approach of generating Last Observation Carried Forward (LOCF) data on visit wise data
• Provided SAS programming support to Statisticians and Data Managers to develop Clinical Reports.
• Responsible for writing and debugging statistical programming and documented programming procedures.
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Used standard and global macros for specific needs to improve teh quality of work. Modified company standard macros as per study level

Environment: SAS9.3, SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, PL/SQL, SAS/CONNECT, SAS/ACCESS, SAS/ODS, SAS/EG, SAS/GRAPH, Oracle Clinical, WinSQL, MS Office, MS Visio, MS Project, Share Point, Windows

Confidential, Philadelphia, PA

Clinical SAS Programmer

Responsibilities:

• Program, analyze and evaluate Phase me-IV Clinical Trial data using SAS.
• Worked on Clinical Trials data like Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (LB), Physical Examination (PE) and vital signs (VS).
• Reviewed clinical study protocol, case report form (CRF), annotated teh CRF and provided comments for electronic CRF (eCRF).
• Validated teh edit check program and teh reports for quality control process.
• Reviewed statistical analysis plan, mock-up’s/shells/templates, and provided comments as needed.
• Familiar wif updating mock-up as per new study design.
• Referring teh statistical analysis plan (SAP), analysis dataset specification was developed and developed analysis dataset programs.
• Validated and maintained status on quality control document for teh team, validation TEMPhas been performed as specified in teh QC tracking sheet.
• Generated safety, efficacy, and graphs as mentioned in teh template and validated as per teh QC tracking sheet, used SAS Output Delivery system (ODS) for generating reports in specific output formats like RTF, PDF, and HTML.
• Used, customized, developed company/therapy/study level macros for generating tables, listings, graphs.
• Involved in teh process of generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• DevelopedAnalysisDatasets following teh ADaM Implementation guide and Specifications.
• Worked on Statistical Analysis and generated Reports, Listings and Graphs using BASE SAS and SAS procedures such as PROC SUMMARY, PROC TABULATE, PROC FREQ and ODS.
• Performed Edit check programming to identify potential data issues and conducted data validations as per data dictionary guidelines.
• Generated SDTM and ADaM Datasets as per Implementation guide and Specifications.
• Created project specific macros and formats and used teh existing study level macros to ensure consistency and integrity.
• Prepared/reviewed CRF and annotated CRF for clinical trials.
• Worked wif different CDISC data models such as SDTM, ADaM and Define.xml
• Provided SAS programming support to Statisticians and Data Managers to develop Clinical Reports.
• Responsible for writing and debugging statistical programming and documented programming procedures.
• Established and maintained sound working relationship and effective communication.

Environment: SAS 9.1.3, & 9.2 for, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/CONNECT, SAS/MACROS, SAS/ACCESS, WinSQL, MS Excel, MS Access, Oracle, IP Switch, Windows.

Confidential, Buffalo, NY

Clinical SAS Programmer

Responsibilities:

• Worked on Various Phases (me - III) of Clinical Trial Data
• Created tables, listings and graph to generate clinical study reports for teh collected requirement from teh statisticians referring to teh Statistical Analysis Plan (SAP).
• Extracted data from ORACLE database and involved in cleaning teh data using various edit check techniques.
• Used procedures like Proc Transpose, and Proc Sort, in data transformation and manipulation processes.
• Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Printto and Proc Compare for checking teh assumptions and conducting Statistical Analysis.
• Produced Ad hoc reports of various kinds like listings, tables, and figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Proc Summary, Proc Print, Data Null technique, and Proc Gplot etc.
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML
• Prepared specifications and programming of mapping raw datasets to CDISC SDTM Standards.
• Generated SDTM and ADAM Datasets using CDISC Standards and performed SDTM Validation Checks.
• Involved in generating various e-submission deliverables for teh FDA.
• In-depth knowledge of statistical analysis techniques for clinical studies.
• QC SAS Programs to generate appropriate Tables, Listings and reports to support data cleaning activities according to data manager requirements.
• Created SAS output RTF and PDF files using Output Delivery System (ODS) Facility.
• Established and maintained libraries of fully documented and validated SAS programs/ macros / procedures used.
• Ensured proper and consistent implementation and maintenance of guidelines and standards wifin teh department.

Environment: SAS/BASE, SAS/STAT, SAS/MACROS, SAS/Enterprise Guide, SAS/SQL, SAS/ODS, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, Oracle Clinical, SQL Server, WinSQL, MS Excel, MS Word, MS Project, Share Point

Confidential, Ann Arbor, MI

Clinical SAS Programmer

Responsibilities:

• Developed new or modified SAS programs to load data from teh source and create study specific datasets.
• Performed data analysis, statistical analysis, predictive analysis and generated reports, listings and graphs using SAS tools e.g., SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL, SAS/ODS, SAS/STAT, SAS/Connect and SAS/Access
• Developed Mappings between Source and Target and Validated Data for missing values and created TLGs based on teh requirements.
• Responsible for creating SAS data sets like AE (Adverse Events), MH(Medical History), DM (Demographics), PE (Physical Examination), VS (Vital Signs), SC (Subject Characteristic), LB (Laboratory).
• Extensively handled MACROS and SAS BASE procedures such as Proc Print, Proc Tabulate, Proc Report, Proc Summary, Proc Sql, Proc Means, Proc Freq, Proc Transpose, Proc Contents, and Proc Format.
• Wrote independent SAS programs to create, validate TLG, analysis datasets, and SAS standard macros for Phase II, III studies.
• Created Kaplan-Meier Survival Curves using PROC LIFETEST, PROC PHREG and PROC GPLOT in SAS.
• Maintained studies document as per teh FDA rules and 21 CFR parts 11 regulations.
• Extensively performed Data Cleansing and Data Validation by analyzing teh raw data and writing SAS Program and SAS Macros
• Provided programming support in compliance wif relevant SOPs and working practices. Generated tables using Proc Report, Proc Tabulate, and Proc Print procedures.
• Used SAS/ODS to generate reports on HTML web format as well as in RTF and PDF formats.
• Extensively used Base SAS, SAS/Macros, SAS/Graph, and SAS/Stat. Also used SAS DATA NULL and PUT statements to create teh customized reports.
• Validated, documented and tested component programs in an efficient manner for inclusion in integrated reports.
• Developed SDTM data mapping and created SDTM domains such as AE, LB, DM, SE, EG, EX, IE etc. and their SUPPQUAL datasets.
• Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Extensively used SAS Macro options such as MPRINT, MLOGIC and SYMBOLGEN to test and debug existing macro programs.
• Used teh CDISC-SDTM to CRT-DDS transformation to transform SDTM domains into a define.xml file.
• Reviewed and provided feedback for Data Integrity Plans.

Environment: SAS 9, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACROS, SAS/CONNECT, SAS/ACCESS, SAS/ODS, MS Access, MS Office, SQL Server, WINDOWS.

Confidential

SAS Programmer

Responsibilities:

• Provided SAS Programming using SAS/Base, SAS/STAT, SAS/Macros and SAS/ODS.
• Worked in II and III Phases of clinical Data. Worked extensively wif SAS Functions/Macros/Procedures.
• Created teh designated Tables, Figures, and Listings according to teh Statistical Analysis Plan (SAP) and following teh guidelines of teh Programming Manager.
• Validated teh analysis datasets, TLG’s by Independent programming. Extracted data from Oracle using SQL Pass through facility
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs
• Developed new or modified SAS programs to load data from teh source and create study specific datasets, which are used as source datasets for report generating programs
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros
• Generated Tables, Graphs and Listings for inclusion in Clinical study reports and regulatory submission.
• Participated in preparing study results as well as ISS and ISE for FDA submissions.
• Modified macros for report generation using SAS Macros as per teh statistician’s requirements
• Developed efficacy and safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables
• Generated summary reports, listing and graphs using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL and UNIVARIATE
• Wrote programs in SAS to generate reports, creating RTF, HTML listings, tables and reports using SAS/ ODS for Ad-Hoc report generation. Knowledge of CRF-Annotation wif respect to various database designs.
• Performed verification of SAS-generated outputs (tables, listings and graphs) via independent programming.
• Carried out all activities according to SOPs. Ensure adherence to programming guidelines.

Environment: SAS 9.1, 9.2 on UNIX and Windows wif following modules, SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/SHARE, SAS/MACROS, SAS/ACCESS. SAS/CONNECT, PL/SQL