SUMMARY:

• SAS Programmerwith 6 Years of IT Experience in SAS Programming experience in developing statistical reports and statistical analysis.
• Significantly and productively contributed to the development team by producing well planned, high quality software using advanced programming skills in biopharmaceutical clinical research environment.
• Broad Knowledge of Life Sciences with extensive experience in the clinical trial process (Phase I - IV).
• Extensive experience in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, SAS/ODS, SAS/SQL.
• Proven experience using SAS with relational databases (Oracle, Teradata, Sybase and SQL Server) on both UNIX and Windows platforms.
• Involved in creating specifications for Analysis datasets involved in safety and efficacy statistical analysis.
• Involved in creating various SAS Reports (Tables, Listings and graphs) satisfying the 21CFR-11 (Code for Federal Regulations) for electronic data submission.
• Extensively involved with validation of reports based on company specific SOPs and 21CFR Part 11 code of federal regulations for electronic submission.
• Worked with Data managers to clean data for biostatistics and also provide SAS programming assistance to program complex edits.
• Working knowledge of database design/structures.
• Extensive knowledge of both CDISC SDTM and ADaM models.
• Mapping experience in conversion of raw datasets to CDISC compliant datasets.
• Having good experience on pooling studies especially in clinical pharmacology studies
• Worked with MEdDRA and WHO-DRUG data.
• Experience in both Windows and UNIX environments.
• Interacted with senior Bio-statisticians and clinical data managers to provide SAS programming in analyzing the data, generating reports, tables, listings and graphs.
• Extensive experience in extracting clinical data from various databases like Oracle, Oracle Clinical, Clin Trial, Teradata and SQL Server.
• Experience in Integrated Summaries of Efficacy (ISE) and Safety (ISS) according to Statistical Analysis Plan (SAP) and Protocol.
• Thorough knowledge in Post Marketing study analysis and IMS Prescription data analysis.
• Strong working knowledge of FDA regulations, ICH Guidelines and GCP requirements.
• Extensive knowledge of SAS / Graphs
• Ability to work in high speed, hectic environment with a sense towards urgency and prioritizing responsibilities by working independently but also cohesively in the team with positive demeanor executing analysis plans, meeting the deadlines.
• Exceptional verbal and written and strong communication skills in particular explain complex technical concepts and applications to both technical and non-technical audience at ease.

TECHNICAL SKILLS:

• SAS : SAS 9.x/8.x (SAS/BASE, SAS/MACRO, SAS/ACCESS, SAS/GRAPH, SAS/STAT, SAS/SQL )
• Databases: Oracle 10g/9i, SQL Server 2000, MS Access, Teradata, Sybase
• Reporting Tools: Reports 2.5, Crystal Report 5.0
• Languages: C, SQL, PL/SQL, Visual Basic 6.0
• Operating System: Windows 95/98/NT2000, UNIX/LINIX

Education:

• Master of Science in Microbiology.
• Bachelor of Science in Microbiology & Chemistry.

EXPERIENCE:
Confidential, Houston, TX Dec 2010 - Present
SAS Programmer/Analyst
Confidential is a private biotechnology company developing a first-in-class molecule with activity in several types of cancer and in other indications with unmet medical needs. The Company is also investigating the activity of the oral formulation of XXXXXXXXXX in patients with severe sepsis in an NIH-funded clinical trial. The data was collected on designing of Phase I to phase III clinical trials. The objective of the studies is to determine the safety and efficacy of the investigational product.
Responsibilities:

• As a sas-programmer reviewing and proving comments on SAP and templates.
• Preparing tracking sheet and planning, assigning the required tasks to team members.
• Co-ordinated with statistician and generated analysis dataset specifications using annotated eCRF and database specifications as per available templates.
• Developed new or modified SAS programs to load data from the source and created study specific datasets.
• Generated analysis safety and efficacy datasets based on dataset specifications
• Generated safety statistical analysis reports such as tables, listings, and graphs for safety data as per available templates
• Pooling of raw datasets from different studies to pool environment as per the specifications.
• Creating specifications for pooling studies as per requirement.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs for phase I to phase III trials.
• Providing statistical programming support for HA requests.
• Extensively involved in the process of validation such as datasets validation and tables, listings validation.
• Generated tables, listings and graphs by using various procedures, PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC UNIVARIATE, and PROC GCHART and PROC GPLOT.
• Extracted data from Oracle data base by using SQL Pass through facility.
• Extensively used SAS/ODS to produce HTML, PDF and RTF format files.
• Preparation of Integrated Safety (ISS), integrated Summary Efficacy (ISE), Electronic Common Technical Document (e-CTD) and Case Report Tabulation (CRT).
• Trained in Good Clinical Practice (GCP), Regulatory Compliance, FDA Guidelines.
• Data interpretation, supporting statistical methodologies and review SAP.
• Proficient in understanding of Study Protocols, SAP (Statistical analysis plan), and CRF.
• Excellent ability in problem solving, data analysis, complex reports generation.
• Attended project team meetings, interacted with Bio-Statisticians, Data Managers, and Clinical Research Managers and with medical writers.
• Prepared test plans and tested respective programs changed or created.
• Created datasets from flat files and excel worksheets, and also created analysis data sets.
• Developed pooled datasets and manipulated by using sorting, merging and concatenating techniques.
• Created SAS Customized Reports using the Data _Null_ technique.
• Involved in writing code using BASE SAS and SAS/Macros to extract, clean and validate data from oracle tables.
• Providing statistical support for CSR(clinical study report) for completed studies
• Participated in project meetings, presentations and updating research findings.

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/ACCESS, SAS/ODS, Oracle, Teradata, UNIX, MS Access, Excel.
Confidential, PRINCETON, NJ Aug2008-Nov2010
Clinical SAS Programmer

Confidential Inc in Princeton, NJ is a private company categorized under Laboratories-Research and Development. Confidential engages in the discovery, development, and commercialization of human antibody-based therapeutics to treat cancer, inflammation, autoimmune disorders, and infectious diseases.
Responsibilities:

• Providing statistical programming support per on-going studies as per CTH request with inputs from statistician.
• Successfully provided programming support in analyzing and implemented Phase I, II and III Clinical Trials.
• Produced customized reports by using TABULATE, REPORT, and SUMMARY, provide descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE.
• Reading the raw clinical data, validating, manipulating, sorting and merging the data.
• Providing statistical support for generating eRPL book marking for FDA submission studies.
• Involving in data review by co-ordinating wih e-CRF development team and generated required listings as per analysis plan(ex. PD’s)
• Generating and validating patient profiles for the different studies
• Generate summary tables, patient listings and develop different types of statistical reports by using Import Techniques and modified existing datasets using edit checks, Set, Merge, Sort and SAS Functions and operators.
• Provided statistical SAS programming for biostatistics and data management deliverables that support both in-house clinical (or pre-clinical) studies and prospective, ongoing clinical trials per GCP and ICH standards/regulations.
• Involved in review of the Protocol, annotated CRF, Specifications, and Mockups for data clarification, creation, derivation, and verification.
• Performed primary and secondary safety analysis and displayed demographics, discontinuation, adverse events, lab, vital signs, exposure and other safety data.
• Prepared efficacy and safety summary results with tables, data listings, graphs/box plots and reports.
• Performed statistical analysis, generate reports, listings and graphs using SAS/Base, SAS/MACROS and SAS/GRAPH, SAS/SQL, SAS/REPORT.

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/ACCESS, SAS/ODS, SAS/GRAPH, SAS/REPORT, SAS/ODS, Oracle, Windows.
Confidential, Baltimore, MD Oct 2007 - July 2008
SAS Programmer - Clinical Trials
Confidential is a fully integrated pharmaceutical company that discovers, develops and markets novel pharmaceutical products targeting the cancer and other disorders. As a SAS programmer my role is in analysis of Clinical trial data and generating required reports, listings, summaries and Graphs for submission to FDA and other regulatory authorities.
Responsibilities:

• Preparing tracking sheet to track the study plan and assigning programs to team members.
• Creating, Updating input documents for essential macros of the study(such as titles and foot notes).
• Modifying the major macros as per the study requirement
• Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation, including testing SAS code.
• Prepare clinical data listings and summaries for statistical analysis and analyzed clinical data using SAS system.
• Developed reports using PROC REPORTS, PROC TABULATE and DATA_NULL_.
• Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
• Provided programming expertise in the generation of data listings, summary tables and graphs for interim and final analysis.
• Prepared, documented and tested required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports.
• Interacted with statisticians to program efficacy tables.
• Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Created Data Definition Tables (DDT) for programming the analysis datasets according to CDISC and protocol specifications with the help of biostatistician to meet future needs.
• Created graphs by using the SAS annotate facility and SAS/GRAPH procedures.
• Maintained and wrote Reusable SAS Macros.
• Generated numerous ad-hoc reports on routine basis
• Successfully handled multiple projects at a time.
• Used SAS for pre-processing data, SQL queries, data analysis, generating reports, graphs and statistical analyses.
• Accessed various database to gather data, performed a table lookup and translated data values for meaning and readability.
• Downloaded data from Oracle using SQL within SAS to be analyzed and exported to Excel for further analysis.
• Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.

Environment: SAS 7/8, SAS/SQL, SAS/BASE, SAS/MACROS, SAS/GRAPH, ANOVA, Oracle 8, PL/SQL, UNIX and Win. NT
Confidential, Chennai, INDIA Jul 2005 - Sep 2007
SAS Programmer
Confidential is one of the reputed Biopharmaceutical companies in India and is involved in developing new drugs in the treatment of various disorders. As a SAS programmer, I performed relevant analysis of administrative and automated claims databases, surveys and economic data captured during clinical trials on Cancer, Cardiovascular and respiratory disorders.
Responsibilities:

• Prepare clinical data listings and summaries for statistical analysis and analyzed clinical data using SAS system.
• Developed reports using PROC REPORTS, PROC TABULATE and DATA_NULL_.
• Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
• Used SAS for pre-processing data, SQL queries, data analysis, generating reports, graphics and statistical analyses.
• Accessed various database to gather data, performed a table lookup and translated data values for meaning and readability.
• Downloaded data from Oracle using SQL within SAS to be analyzed and exported to Excel for further analysis.
• Implemented statistical analysis plans and specification documents.
• Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.
• Produced customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univarate.

Environment: SAS 7/8, SAS/SQL, SAS/BASE, SAS/MACROS, SAS/GRAPH, ANOVA, Oracle 8, PL/SQL, UNIX and Win. NT