SUMMARY

• Certified SAS Programmer with 8 years of experience with Clinical trials, SAS tools and Statistical analysis with emphasis on clinical data analysis, data validation and statistical report generation.
• Experience in Base SAS, SAS/MACRO, SAS/SQL, SAS/ODS
• Skilled in writing macros and conversion of SAS Datasets to various file types (including HTML, RTF, PDF, Excel, CSV) as well as converting various file types to SAS Datasets.
• Extensively used SAS procedures for producing ad - hoc and customized reports and external files.
• Generated, compiled, screened SAS data sets and tested the Sensitivity, Specificity and Clinical reliability of the data.
• Hands on experience in creating NONMEM ready analysis datasets for different PKPD dataset modules LABSEXEF, POPPK, PKCONC, PKPARAM, LABS, EFFICACY, PD etc.
• Familiar with 21 CFR Part 11 compliant Statistical Process Control Systems, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP).
• Good knowledge of Confidential, SDTM, ADaM data standards as well as NONMEM data standards.
• Experienced in working on CDARS system, worked on duplicating Protocols, setting up tables, creating Macros and running reports in CDARS.
• Flexible to changing priorities, detail oriented, self-motivated with capacity to coordinate cross functional projects.
• Experience in creation of SDTM and ADaM specifications for Phases I, II and III studies.
• Dataset specification support for NONMEM datasets.
• Working experience in integration of studies for ISS and involved in Mapping, Analysis and Reporting
• Thorough knowledge of Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE) and Safety related data.

TECHNICAL SKILLS

Base SAS Certification: SAS 9.4

Statistical Packages: SAS 8. */9. *, MS Excel.

SAS Tools: SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/CONNECT, SAS/ODS, SAS/MACROS

Databases: Oracle, Microsoft SQL Server, SQL, MS-Access

Operating Systems: Windows 98/NT/XP/Vista/7, Unix, Linux

PROFESSIONAL EXPERIENCE

Confidential

Clinical SAS Programmer

Responsibilities:

• Processed clinical data for analysis of clinical trials for Phase I, II, and III clinical trials.
• Responsible for developing the SAS programs following the information stated in Statistical Analysis Plan (SAP).
• Experienced in writing specifications (Programing Plan) from DRF for creating PKPD related datasets.
• Worked on SAS programming supporting NONMEM, pharmacometrics analysis ready datasets.
• Wrote statistical programs for analyses datasets, tables and listings for clinical study reports.
• Performed QC for datasets by writing independent programs.
• Pooled data across multiple studies for Integrated Summary of Safety (ISS)
• Created Specifications for Pooled study ADaM datasets
• Created datasets according to Confidential SDTM and ADaM standards using SAS Programming.
• Involved in QC/Validation of Confidential SDTM and ADaM data sets.
• Validated generated tables and Listings via independent programming.
• Supported with eSub work for checking datasets as per specification
• Created ad hoc programs to provide information as per the requests from FDA.

Confidential

Clinical SAS Programmer

Responsibilities:

• Reviewing Mapping Specifications comparing with Data Transfer Plan, Form Specification, Raw data related to Questionnaire data (QS) for CNS domain.
• Creating and Maintaining SAS programs to build SAS datasets from Clinical Database.
• Utilizing SDTM guidelines to build SAS Datasets.
• Performing Quality checks and ensuring the data from database is correct by writing QC program and running Proc compare.
• Providing mentorship and guidance to Clinical Data Scientist for SAS programing.
• Worked on transitioning studies from SQL server into SAS.
• Worked on documentation, assisted in writing SOP’s, Work Instructions.
• Ability to work well with others and independently.

Confidential

Responsibilities:

• Worked on CRF annotations using SDTMIG.
• Developed data sets by subsetting, appending, merging data with conditional processing using SDTMIG and Data specs from raw datasets.
• Performed data checks, identified data issues and coordinated with data management team to resolve the data issues.
• Developed SAS programs for converting SDTM dataset to ADaM dataset.
• Developed SAS programs for ADaM datasets and Tables/Listing/Figures for analysis as per the SAP.
• Performed Quality Control of SDTM and analysis datasets by independent programming.
• Created Analysis Datasets - Confidential ADaM like ADVS
• Developed programs for report generation using PROC REPORT and SAS/ODS
• Performed Quality control of reports.
• Generated the Graphs by employing SAS Procedures such as Proc Gplot, Proc Gchart, Proc Sgplot.
• Attended Confidential training and have good understanding of SDTM and ADaM guidelines.
• Ability to co-ordinate and work with virtual team.

Confidential | Connecticut

SAS programmer

Responsibilities:

• Processed clinical data for analysis of clinical trials for Phase I, II, and III study.
• Developed new SAS programs and modified existing SAS programs.
• Worked as QC programmer for TLF.
• Experienced in writing specifications (Programing Plan) from DRF for creating datasets.
• Hands on experience in creating NONMEM ready analysis datasets for different PKPD dataset modules like LABSEXEF, POPPK, PKCONC, PKPARAM, LABS, EFFICACY, PD etc.
• Maintained and enhanced existing SAS programs for deriving datasets and for generating NONMEM ready analysis datasets
• Involved in all activities of clinical data management, tracking, cleaning, querying and updating from query resolutions
• Experience in importing and exporting raw data files, manipulating and transforming data, combining SAS data sets.
• Performed validation on derived datasets by following the standard operating procedures via independent programming.
• Performed Quality review on all program files for accurate historical review and documented files for future reference.
• Coordinated work on multiple projects according to priorities.
• Worked on multiple projects, included studies from various Therapeutic areas like Inflammation/Immunology, Neurology & Pain, Cardiovascular, Metabolic disease.