Clinical Sas Programmer Resume
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Princeton New, JerseY
SUMMARY
- Certified SAS consultant with 3+ years of SAS programming experience in Pharmaceutical and CRO industries.
- Worked extensively on various therapeutic areas like Cardiovascular, Oncology, Respiratory, and Pain.
- Extensive experience working with various SAS modules like SAS/Base, SAS/Macros, SAS/SQL, SAS/Stat, and SAS/ODS.
- Experience working in all the phases (I to IV) of clinical trials.
- Expert in using SAS/ODS to create Ad - hoc RTF, HTML, PDF, and Listing output reports.
- Extensively used various SAS procedures like Proc Transpose, Proc Univariate, Proc Summary, Proc Means, Proc Freq, Proc Compare, Proc Contents, Proc Sort, and Proc Print.
- Involved in the process of generating Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA Submission.
- Involved in clinical data analysis and creating ADaM and SDTM datasets, reports, tables, listings, summaries and graphs according to Statistical Analysis Plan (SAP) and departmental guidelines in Standard Operating Procedures (SOP).
- Worked with different clinical trials data like Demographic, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory-chemistry/Hematology/Urine analysis, and Vital signs.
- Proficient in Quality Control/Validation of analysis datasets according to SOP standards.
- Excellent team player with ability to work individually as well as in teams.
- Highly motivated and consistently meets aggressive deadlines.
- Knowledge of CRF-Annotation.
- Making efficient usage of SAS functions and procedures, including common statistical procedures.
TECHNICAL SKILLS
SAS Tools: SAS /BASE,SAS /Macros,SAS /STAT, SAS/GRAPH, SAS/SQL, SAS/ODS,SAS /Enterprise Guide
SAS Procedures: PROC Report, Print,Freq, Means, Summary, Univariate, SQL, Sort, Transpose Contents, Options, Import, Export, Format, etc.
Operating Systems: Windows (95/98/2000, XP, 7), UNIX
Applications: MS Office, MS PowerPoint, MS Access, MS outlook,SAS /Add-in
Databases: MS SQL Server,Oracle, MS-Access.
PROFESSIONAL EXPERIENCE
Confidential, Princeton, New Jersey
Clinical SAS Programmer
Responsibilities:
- Worked extensively to generate SAS data sets, statistical reports, listings, safety reports for Phase III & IV ofAlzheimer's DiseaseClinical Trial Data.
- Developed and validated Tables, Listings and Figures (TLF’s) according to the shells and specifications provided in the Statistical Analysis Plan (SAP).
- Programmed and validated Analysis Dataset Model (ADaM) datasets according to study protocol specifications.
- Pooled the clinical data forAlzheimer's Diseasestudies and generated Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) reports.
- Generated Descriptive and Statistical summary outputs using Proc Means, Proc Freq, and ProcUnivariate.
- Created outputs in PDF, RTF and HTML formats by using SAS ODS.
- Performed validation of TLFs and logged QC issues in validation documentation with detailed explanation.
- Extensive use of Import/Export procedures to convert SAS data into CSV and Excel data and to convert Excel data into SAS data.
- Used statistical SAS procedures like Proc Means and Proc Freq for tabulation counts and data validations.
- Involved in fixing the Pinnacle21 report errors and warnings.
- Created various ad-hoc reports as per the statistician’s request.
Confidential, Durham, North Carolina
Clinical SAS Programmer
Responsibilities:
- Provide SAS programming support on Phase IIIStudies ofCOVID-19Vaccine.
- Programmed Study Data Tabulation Model (SDTM) datasets according to the CDISC standards for the clinical study.
- Validated Analysis Dataset Model (ADaM) datasets according to study protocol specifications.
- Generated Tables, Listings and Figures (TLF’s) according to the shells and specifications provided in the Statistical Analysis Plan (SAP) for the clinical study.
- Extensive use of Import procedure to convert Excel data into SAS data.
- Involved in creating Transport-files for electronic submissions to FDA.
- Created outputs in PDF, RTF and HTML formats by using SAS ODS.
- Used statistical SAS procedures like Proc Means, Proc Freq and proc Compare for tabulation counts and data validation.
Confidential, Denver, CO
Clinical SAS Programmer
Responsibilities:
- Developed Study Data Tabulation Model (SDTM) data sets according to the CDISC standards for clinical studies.
- Worked extensively to generate SAS data sets, statistical reports, listings, safety reports for Phase I to III of Cardio-Vascular Clinical Trial Data.
- Generated Tables and Listings according to the shells and specifications provided in the Statistical Analysis Plan (SAP).
- Performed validation of TLFs and SDTM data sets for clinical studies and entered issues in validation documentation.
- Extensively used Proc Import to create SAS data sets from Microsoft Excel sheets.
- Validated the results for statistical reports by using procedures like Proc Univariate, Proc Freq and Proc Compare.
- Performed Validation and quality control (QC) operations on SAS programs written by other statistical programmers.