SUMMARY

• Over 4 years SAS programming experience in analysis, design and development of statistical applications including data extraction and manipulation, reporting on projects with various industries like pharmaceutical, health care, and bio - sciences
• Experience working with various SAS modules like SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL, SAS/Stat, SAS/ODS, SAS/Access
• Expertise in SAS programming with statistical background in phase I, II, and III of clinical trials
• Experience in implementing CDISC SDTM standards for intervention, event and findings domain models and ADaM standards
• Extensive experience in generating SDTM domains for DM (Demographics), MH (Medical History), CM (Concomitant Medication), CO (Comments), AE (Adverse Events), DS (Disposition), DV (Protocol Deviation), EX (Exposure), PC (Pharmacokinetic Concentration), VS (Vital Signs), PP (Pharmacokinetic parameters), PE (physical Examination), SE (Subject Elements), SU (Substance Use), SV (Subject visits), TA (Trial Arms), TE (Trial Elements), TI (Trial Inclusion/Exclusion criteria), TS (Trial Summary), TV (Trial Visits) and their SUPPQUAL datasets by following CRF, Dataset Specifications
• Expert in using SAS/ODS statements and Data null to create RTF, PDF, HTML, XPT and Listing output reports
• Extensively used various SAS procedures like Proc Report, Proc Means, Proc Univariate, Proc Tabulate, Proc Contents, Proc SQL, Proc Gplot, Proc Gchart and Proc Glm
• Expert in the process of generating tables, listings in compliance with 21 Code of Federal Regulations (21CFR) Part 11, FDA, ICH/GCP guidelines and also involved in programming for ISS (Integrated Summary of Safety) for FDA Submission
• Experience in implementing corporate quality standards, ICH/GCP, FDA and other international regulatory requirements to upgrade/change system based applications
• Review and provide inputs for essential trial documents such as protocol, CRF, data management plan (DMP) and statistical analysis plan (SAP)
• Worked with different clinical trials data like DM, AE, MH, CM, VS, PE, LB (Laboratory test results) and many other study specific datasets
• Proficient in Quality Control/Validation of analysis datasets according to SOP standards
• Proficient in using basic UNIX commands and experienced in working on both UNIX and Windows versions of SAS
• Development of SAS programs for the creation of analysis datasets
• Knowledge of CRF-Annotation used various database design
• Familiarity with medical dictionaries like MedDRA and WHO
• Excellent team player with ability to work individually as well as in teams
• Highly motivated and consistently meets aggressive deadlines

TECHNICAL SKILLS

SAS Tools: SAS /BASE, SAS /Macros, SAS /STAT, SAS/GRAPH, SAS/SQL, SAS/ODS

SAS Procedures: PROC Report, Print, Freq, Means, Univariate, SQL, Sort, Transpose, Contents, Options, Import, Export, Format, etc.

Operating Systems: Windows (95/98/2000, XP, 7,8), UNIX

Applications: MS Office, MS PowerPoint, MS Access, MS outlook, SAS /Add-in

Databases: MS SQL Server, Oracle-Clinical, Excel, MS-Access

PROFESSIONAL EXPERIENCE

SAS Programmer/Analyst

Confidential, Madison, NJ

Responsibility:

• Carefully reviewed various study related documents like protocol, statistical analysis plan (SAP), case report form (CRF), statistical programming specifications (SPS), List of tables (LoT) etc
• Strong experience in SAS data step programming for data manipulation, processing, quantitative and qualitative analysis and report writing
• Extensive experience in extracting data from flat files, spreadsheets and external RDMS (Oracle) tables using statements - libname, % include, proc import, access and SQL pass through facility
• Generated data review plan (DRP) listings for preliminary results before DBL
• Created derived datasets of different domains like DM, PE, MH, CM, AE and VS from the raw data by using various SAS techniques like - proc format, functions, proc contents, proc transpose etc
• Worked as primary programmer to produce tables, listings and figures for the clinical study report (CSR)
• Generated various kinds of safety and efficacy tables by following table shells, SAP and SPS
• Worked extensively on creating statistical reports by following various sas techniques like proc means, proc freq, proc summary, proc univariate, proc report, proc template etc
• Worked on PK studies and experience in generating statistical results like Arithmetic mean, Geometric mean, Coefficient of Variation (CV), N-active etc.
• Worked with inferential statistics like p-value (ANOVA), 95% confidence intervals (C.I), Hazard ratio, Gamma statistic, Adjusted mean (LS Mean), Standard Error (SE), Treatment difference (of adjusted mean) (trt diff), power, Intrasubject CV%, RMSE (root mean square deviation), AUCL, AUCI (area under the drug concentration - time curve), Cmax(maximum observed drug concentration), Tmax (time to maximum observed drug concentration), Thalf (elimination half-life), Kel (elimination rate constant), CL (volume cleared by the system), Vd (volume distributed during the log linear phase), etc
• Worked as validation programmer in generating TLFs and performed QC following QC checks
• Developed routine sas macros to create tables, listings and figures for inclusion in clinical study reports and maintained existing ones
• Experience working with PK/PD data
• Responsible for coding, debugging programs at various stages of study and submitting statistical reports as per ad hoc query at various stages of clinical trials
• Worked extensively in Unix environment

Environment: PC SAS 9.4, UNIX SAS 9.2 (WRQ Reflection X manager-GSUN81), FTP Client

SAS Programmer

Confidential, Seattle, WA

Responsibility:

• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis
• Developed programs to prepare the safety and efficacy tables, listings and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated analyses data sets
• Established domain models according to SDTM specs and also created new domains that are CDISC compliant and Implemented CDISC SDTM standards
• Created CTR Datasets used for FDA Submissions using CDISC standards
• Used Output Delivery System (ODS) facility to write custom safety and efficacy reports directing sas output to RTF and Excel files
• Generated tables, listings, graphs and analysis datasets (ADS) using various procedures like proc freq, proc report, proc tabulate, Data null and proc gplot
• Developed routine, user-friendly SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions
• Produced tables, listings and graphs for Integrated Summary of Safety (ISS)
• Performed data validation and data cleaning by peer-reviewing
• Statistical analysis included coding the data sets, calculating simple percentage distributions, graphs, comparison of rates by agency’s t-test and chi-square test and generating multiple tables and reports
• Performed validation activities to ensure the quality of the electronic submission, and contributed towards creating tables, listings and validating the analysis datasets as per the data specifications
• QC of End of Text Material (EOT) for TLF’s for given trial
• Performed ad hoc programming as per client’s requests

Environment: PC SAS 9.2

SAS Programmer/ Analyst

Confidential

Responsibility:

• Analyzed the clinical data of Phase I, II and III for multiple studies
• Responsible for creating, testing and maintaining SAS programs for clinical studies according to company standard procedures
• Generated derived data sets from raw data sets using proc sort and used merge, set, format and functions
• Generated various kinds of reports like tables, listings, and figures (TLGs/TLFs), using proc report, proc template, proc gplot etc
• Examined and analyzed data utilizing data cleaning and data validation techniques in compliance with 21 CFR part 11 regulations
• Implemented statistical analysis, and created tables, listings, and graphs using SAS Base, Macros, and SAS Graph
• Worked with different clinical trials tables like Demographic (DM), Medical History (MH), Vital signs (VS), Adverse Event (AE) and Physical examination (PE)
• Responsible for coding, debugging, generating listings, analysis of output and reporting
• Wrote quality control programs for various reporting stages and also generated analysis datasets
• Generate independent SAS code for quality checking of other programmers' code, follow SOP guidelines to check data and programming integrity; reviewing LOG messages, using proc mean, freq, compare etc
• Analyzed, summarized, and reported clinical data for new drug applications. developed, tested, validated and documented statistical summary and analysis programs
• Used Output Delivery System (ODS) facility to write safety and efficacy reports directing SAS output to RTF listings, tables and reports
• Extensive use of the SAS Macro facility to create tables, listings and graphs
• Imported/Converted randomization data files from Excel, .CSV data files into SAS data sets for analysis
• Performed SAS Edit Checks on the raw SAS data sets
• Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output

Environment: PC SAS 9.2