SUMMARY

• SAS Certified Professionalwith 9 yearsof experience in Clinical and Pharmaceutical Industry. Experience in data analysis by using Clinical SAS includes detailed knowledge in all phases of clinical trials and good Command in statistical analysis and research, data management, programming, production of reports, tabulations, graphs, listing of clinical data, and robust knowledge of Base SAS, SAS/Macros, SAS/SQL, SASSPDS in both Windows and Unix Environment.
• Familiar with SAS 9.2 and 9.4 in SAS versions. Creation of new datasets from raw data files using import and infile techniques and modified existing datasets using SET, MERGE, UPDATE and CONDITIONAL statements.
• Good working knowledge on SDTM domains like Demographics (DM), Concomitant Medication (CM), Exposure (EX), Adverse Event (AE), Medical History (MH), Disposition (DS), Vital Signs (VS).
• Experience in cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
• Strong experience usingSAS/GRAPH to produce Graphs by employingSASprocedures such as Proc Gplot and Proc Gchart.
• 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.
• Experience in producing reports, employing various SAS procedures like PROC SQL, PROC REPORT, PROC FORMAT, PROC FREQ, PROC PRINT, PROC MEANS, PROC UNIVARIATE and PROC SUMMARY and DATA NULL .
• Used base SAS procedures PROC FREQ, PROC SQL, PROC SORT, PROC Transpose and PROC MEANS to validate current results with expected results.
• Excellent programming skills in SQL and understanding of data management principals, such as joining data sets, data aggregation and sub - setting using PROC SQL.
• Experience in producing EXCEL, RTF, PDF, HTML files using SAS ODS facility.
• High proficiency in Understanding of clinical trial Study Protocol, Design document, SAP (Statistical Analysis Plan), and CRF/eCRF (Case report Form), annotated case report forms and company Standard Operating Procedures (SOP).
• Expertise in transforming data imported from disparate data sources into analysis datastructures, usingSASfunctions, options, ODS, array processing, macro facility, and storing and managing data inSASdata files. Developed Patient profiles.
• Created SAS datasets (.xpt files) for electronic submission as per client requirement.
• Creation of XML-based metadata (teh eXtended Mark-up Language) document is a standalone JAVA application dat contains transmission, validation, and interpretation of data is prepared by teh application of SAS tools.
• Creation ofCase Report Tabulation DataDefinitionSpecification (CRT DD) (Define.xml) is a document dat FDA’s eCTD study data specifications required for drug submission in teh SDTM format.
• Developed tables, listings and figures, for Clinical studies and prepared regulatory documents for FDA submissions.
• Generation of reports using proc Report and Summarizing clinical trial data according to teh SAP (Statistical Analysis Plan).
• Good experience in Phase me to Phase IV Clinical Drug Trail studies. Understanding of clinical trial practices, procedures and methodologies.
• Knowledge ofClinical Terminology and regulatory Guidelines.
• Knowledge of regulatory requirements and Drug Development process.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) process related to data standards including Study Data Tabulation Model (SDTM) and Analysis Dataset Models (ADaM).
• Generating SDTM and ADaM datasets using SAS as per sponsor specifications.
• Validating SDTM and ADaM datasets.
• Working Knowledge of CDISC, SDTM, International Conference of Harmonization, Good Clinical Practice (ICH GCP) and FDA guidelines.
• Understanding of SAS to evaluate a wide range of data types and to perform analyses according to analysis plans.
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
• Knowledge of ANOVA (Analysis of Variance) predictive model t-Test, one-way ANOVA, nonparametric one-way ANOVA, linear models and mixed linear model.
• Work assignment among teh team and coordinate with study statistician and team to get work done with in timelines with quality deliverables.
• Good understanding of regulatory requirements relevant to submissions.
• Good knowledge of clinical trial study design and electronic data submission requirements.
• Knowledge of executing teh test procedures and developing new computer programs.
• Highly self-motivated and goal-oriented professional to work independently as well as in a team environment.

TECHNICAL SKILLS

Statistical Software: SAS v9/v9.2, SPSS

SAS Tools: SASV8,V9, SAS/BASE, SAS/SQL, SAS/Access, SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/Access, SAS/ REPORT, SAS/ODS.

Languages: HTML, SQL, XML

Databases: MS Access, SQL, SAS Clinical

Office Tools: MS OFFICE - Word, Excel, Power Point

Operating Systems: Windows / XP, Vista, Unix, Linux, Mac

PROFESSIONAL EXPERIENCE

Confidential, Quakertown, PA

Sr. SAS Programmer

Responsibilities:

• Involved in managing randomized phase me and phase II clinical trials data.
• Developing projects including designing, coding, implementation and maintenance using technologies such as SAS, PROC SQL. PROC MEANS, PROC FREQ and PROC REPORTS, TABULATE, UNIVARIATE, Append, Array, DO loops, GPLOT and GCHART.
• Developed and validate SAS programs for Tables, Listings and figures.
• Performed Data analysis using SAS Tools - SAS/Base, SAS/Macros and SAS/SQL.
• Reviewed Protocols, Case Report Forms, and Statistical Analysis Plans for Clinical trials.
• Annotated SDTM CRF.
• Developed ADaM specifications. Developed validate SAS programs for SDTM and AdaM datasets.
• Developed Macros, which can be used across various studies.
• Developed SDTM specifications based on CDISC SDTM standards.
• Worked on OPEN CDISC Validator and resolving those errors.
• Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, andClinicalResearch Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans.
• Created various SDTM datasets (AE, EX, DS, LB, CM, DM, VS, IE etc..) from raw datasets.
• Participated in preparing study results as well as ISS and ISE for FDA submissions usingSAS.
• Generated Tables, Graphs and Listings for inclusion inClinicalstudy reports and regulatory submission.
• Converted various SAS data files into transport files (.xpt) using Proc copy for define .pdf documentation.
• Produced quality customized reports by using Proc report and SAS/ODS.
• Worked extensively with data management team in Pharmaco Kinetic (PK) data analysis.
• Work closely with data management, clinical operations, programming, and other biostatisticians to develop and validate study-specific data capture systems.

Environment: SAS v9.1, SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/ACCESS, SAS/ODS, MS OFFICE, ACCESS

Confidential, Blue Bell, PA

TEMPPrincipal Statistical Programmer/Analyst

Responsibilities:

• Involved in programming to support Phase II, III, and IV trials.
• Worked in generation of analysis datasets such as efficacy, adverse events and demographic data sets from raw datasets.
• Worked on teh review process of teh study documents like CRF and other data base design specifications.
• ReviewedClinical study protocols, case report forms and statistical analysis plans forClinical trials.
• Provided SAS programming and analysis support for several studies in close collaboration with other statisticians.
• Extracted datasets from database usingSAS /Access libname statement and other import methods.
• Verified accuracy and integrity ofClinical data by performing validation checks written inSAS and data cleaning by investigating data related errors and missing values.
• Successfully designed and implemented statistical reporting processes for regular data collection andClinical data analysis.
• Worked with variousSAS productsSAS /Base,SAS /Stat,SAS /Graph, andSAS Macros to develop required solutions.
• Developed SAS macro and other utilities to expedite SAS programming.
• Created a highly availableSAS grid computing environment.
• Worked on developing SDTM mapping documents, complete programming and validation ADaM Dataset, also modified teh ADaM file specification based on SAP, DPS and mockup.
• Efficient in using various procedures like PROC FREQ, PROC MEANS, PROC TABULATE, PROC SUMMARY and PROC REPORTand generated patient data listing and various tables as per SAP.
• CreatedSAS XPORT format file as per eCTD guideline usingSAS /Macro, PROC COPY, PROC CPORT.
• Used differentSASprocedures in phase III trial including statistical analysis methods.
• Converted ORACLE data tables intoSASdata files usingSASSQL Pass through Facility, and uploadedSASdata files into ORACLE tables usingSASDbload procedure.
• Collaborated withClinical researchers in teh design ofClinical trial selection ofClinical endpoints, sample size requirements, protocol development, and Research and teh Case Report Form design.
• Wrote SAS program in Unix Platform and wrote report and manipulated data.
• Browsed teh data, worked on teh content and performed frequency on various data sets in SAS on UNIX platform.
• Combined UNIX shell script and SAS codes to get teh needed result for display.
• Involved in creating transport files for electronic submissions to FDA.

Environment: SASV9.3/9.4 on Unix and Windows platform,SASWeb Report, Studio, SAS/ACCESS, SAS/CONNECT, SAS/Macro, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ETL, Excel, Access, E-clinical Works.

Confidential

Clinical Data Analyst

Responsibilities:

• Programming to Support Phase me, II trials.
• Reviewed Protocols, Case Report Forms, and Statistical Analysis Plans for Clinical trials.
• Finding data issues with raw data.
• Involved in clinical trial studies, data migration/extraction of data from Flat files, SQL Tables and SAS datasets.
• Generate teh Tables by using Proc Freq, Proc Means, Proc Transpose and Proc Tabulate.
• Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS.
• Created CRT (Case Report Tabulations) datasets using CDISC standards for submissions to teh FDA.
• Extracted, validated and generated SAS data sets from Oracle; applied 'SQL Pass through Facility'.
• Communicated with Statisticians and Bio-Statisticians to discuss about various SAP related issues and made presentations to discuss about various possible changes in it.
• Maintained appropriate study application documentation.
• Used teh SAS Macro facility to produce weekly and monthly reports.
• Performed Data Validation and Data Cleaning on Clinical Trial data.
• Created and maintained SAS Datasets dat are extracted from an Oracle Clinical Database.
• Created SAS Customized Reports using Data Null technique for FDA regulations.
• Produced Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Created and maintained SAS Datasets dat are extracted from an Oracle Clinical Database.
• Created SAS Customized Reports using Data Null technique for FDA regulations.
• Performed Quality assurance and validation on teh transported data and reports.
• Used procedures like FREQ, MEANS, UNIVARIATE, SORT, PRINT, TABULATE and REPORT.
• Extensively used teh SET, Update and Merge statements for creating, updating and merging various SAS datasets.
• Created listing & summary by using Set, Merge, Proc Means, Proc Freq, Proc Transpose etc.
• Produced accurate, precise tables and listings for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part11, FDA and other regulatory compliance.
• Strong statistical skills with experience in human and/or veterinary clinical studies, in areas such as experimental design, sample size calculation, statistical modelling (including mixed modelling), ANOVA.
• Knowledge of statistical regulatory requirements (FDA, EMA, VICH) for analysing data from clinical studies.
• Knowledge in researching and implementing new statistical methods for various types of data.
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Performed SAS programming using techniques as SAS Base, SAS Macro, data manipulation techniques, and statistical procedures (e.g., Proc Means, Proc Freq, Proc Report).
• Preliminary data validation (clinical data quality checks) is done on teh clinical trial data using SAS/SQL.
• Produced data listings, summary tables and graphs for interim and final analyses and publications using different statements/function/procedure for data manipulation.
• Worked with clinical Data managers in validating teh data entry procedures.
• Involved in multiple clinical projects and MedDRA coding with Data managers.
• Reviewed teh Protocols, Statistical Analysis Plans, Study documents, clinical Study Reports of various studies.

Environment: SAS v8, SAS v9, SAS/SQL, SAS/REPORT, SAS/GRAPH, SAS/BASE, SAS/MACRO, SAS/ODS, MS EXCEL, MS ACCESS, Oracle clinical, Windows.

Confidential

Clinical SAS Programmer

Responsibilities:

• Worked on multiple clinical trials in phase me, Phase II and Phase III.
• Involved in programming, analysis and manipulation of data for Phase II clinical trials in particular therapeutic area.
• Worked on therapeutic areas like Central Nervous system, Oncology.
• Pulled out data from teh Oracle clinical database and prepare customized analysis datasets for specific reporting needs. Generated Tables and Listings as per SAP (Statistical Analysis Plan).
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Reviewed Protocol, CRF, and SAP for creating Analysis datasets, Tables, Listings and Graph’s.
• Analyzed data variables using differentSASprocedures. Teh entire programming part/data step for calculation of likelihood functions was written in SAS/Base, which was incorporated with different procedures like PROC FREQ, PROC UNIVARIATE and PROC REG. Created SAS views from Oracle database usingSAS/ACCESS.
• Used SAS/EG in multi-user environment for intermediate data manipulation, analysis and summary statistics.
• Interacted with data management personnel as necessary to ensure dat datasets are in usable format.
• Worked with clinicians in study design and result interpretation.
• Generated ad-hoc listings depending on request of client. Used Output Delivery System to produce HTML, PDF and RTF reports.
• Designed and validated new and existing programs using Proc Compare and Proc Freq depending on teh requirements. Developed standard macros and used existing macros according to teh requirements.
• Developed and reviewed SDTM data specification according to study CRF and protocol and annotated CRF using SDTM variables. Performed Validation and QC of datasets, tables, listing and graphs.
• Created Tables, Listings and Graphs using various procedures: PROC Report, PROC Tabulate, Data null, and PROC GPLOT as per teh requirement of clinical and data management department.
• Extensively used SAS/ Macro facility to provide reusable programs dat can be conveniently used time-to-time and created tables, graphs and listing reports.
• Created SAS Customized Reports using teh Data Null technique for FDA evaluations.
• Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Involved in creating define.pdf, converting SAS datasets to transport files as a part of E-submissions.
• PROC SQL was used in coding concomitant medications data with WHO drug and medical history data was coded based on MedDRA.

Environment: SAS v8, SAS v9, SAS/Base, SAS/STAT, SAS/MACROS, SAS/SQL, SAS/ACCESS, SAS/Graph, SAS/ODS, Oracle 9i Windows XP.

Confidential

Quality Control/Quality Assurance/Regulatory Affairs Analyst

Responsibilities:

• Carrying out regular audits of facilities, equipment and raw data with in teh Pharmaceutical Section.
• Reviewing stability study protocols, method validations and formulation raw data and/or records.
• Reviewing and authorising Standard Operating Methods/Standard Operating Procedures.
• Responsible for verifying dat teh Process by which work is conducted is as per Standard Operating Procedures.
• Maintain awareness of current GMP regulations as well as ICH and VICH Guidelines.
• Analyse samples from various sources to provide information on compounds or quantities of compounds present.
• Use a wide range of analytical techniques and instrumentation, such as gas, high performance liquid (HPLC) and ion chromatography, electro chromatography and spectroscopy (infrared and ultraviolet).
• Interpret data and adhere to strict guidelines on documentation when recording data and reporting results.
• Develop new techniques for teh analysis of drug products and chemicals.
• Work collaboratively in cross-functional teams and to carry out any other duties as deemed necessary by management. Review label artwork for accuracy and ensure all label requirements are met.
• Zero Production downtime or delays due to label or compliance challenges.
• Organize regulatory documentation into appropriate physical and electronic files including scanning documents into appropriatedocument repository systems. Successful relationships with stakeholders.
• Maintain up-to-date knowledge of health and safety issues in all aspects of work undertaken.