Sr Sas Programmer Resume
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Durham, NC
SUMMARY
- Clinical SAS Programmer with knowledge in SAS (BASE, MACROS, SQL), SDTM, ADaM, TLF’s
- Certified Base SAS Programmer and having good knowledge of advanced SAS with 7 years of experience in analyzing Clinical Trials data for Pharmaceutical and CRO industries.
- Good knowledge of drug discovery process & clinical trial phases.
- Good knowledge of CDISC - SDTM and ADaM, ICH-GCP, GPP, 21-CFR Part 11.
- Knowledge on Clinical Trials - Key Documents like Study Protocol, Case Report Form (CRF) and Statistical Analysis plan (SAP).
- Knowledge on Base & Advanced SAS, SAS/Macros, SAS/GRAPH, SAS/ODS, SAS/SQL and SAS/Report.
- Worked on therapeutic areas such as CNS, CVS and Oncology etc. for all phases of clinical trial.
- SAS Programming experience in generating SDTM, ADAM and TLF’s both standard and non-standard.
- Validated compliance of CDISC datasets by using Pinnacle21, and reviewed P21 reports.
- Experience in defining SAS Macro programs and well versed in debugging the organization level macros while calling the macros.
- Worked on various subgroup analyses for publications, ad-hoc reports and submissions.
- Expertise in producing RTF, PDF files using SAS ODS facility and various other files such as Excel using export for non-standard reports for internal reviews.
- Experience in SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/ODS, SAS/SQL.
- Worked closely with Data Management team and Statisticians.
- Implemented data imputation techniques as per SAP or statisticians’ guidance for questionnaires.
- Experience in generating graphs (KM graphs, scatter plots etc.).
- Well-versed in using organizational specific tools for datasets/reports and concatenating all reports into a PDF.
- Working Environment: SAS 9.4, SAS Enterprise Guide and SAS UNIX.
- An impelled individual with ability to analyze, organize, communicate efficiently and work as a team.
TECHNICAL SKILLS
- Clinical Drug Development Process
- SAS/BASE
- SAS/MACRO
- SAS/SQL
- SDTM
- ADaM & TLF s.
PROFESSIONAL EXPERIENCE
Confidential, Durham NC
Sr SAS Programmer
Responsibilities:
- Worked as Senior Programmer/Validator for various clinical studies.
- Developed client specific analysis datasets and generated statistical reports (TLs) using SAS (Non-standard/Standard).
- Also developed excel documents using SAS programming for non-standard data reports.
- Worked on re-usable generic macros to setup a study and for using in report generation and validation purposes.
- Worked on generating SDTM datasets on CDISC SDTM standards and analysis datasets on ADAM Standards
- Reviewed and understood the study documents (Protocol, SAP & CRF) and implemented the logics needed using programming.
- Performed validation of datasets and Tables, Listings, Figures (TLF's)
- Attended study specific meetings with internal and client team.
Confidential
SAS Programmer
Responsibilities:
- Worked as Trial Programmer and Supporting Programmer/Validator for various clinical studies.
- Reviewed and understood the study documents (Protocol, SAP & CRF).
- Created programming specifications & programming trackers.
- Generated/Reviewed statistical reports (Full Analysis & Safety set and subgrouping) for ongoing studies and scientific analysis.
- Attended study specific meetings with project manager, medical writers, doctors to discuss and provide updates on statistical programming.
- Managed two studies as a Trial Programmer and provided necessary documents to the team in completing the activities.
- Used Macros for generating Tables, Listings and Figures
- Worked with CDISC data models including SDTM, ADAM.
- Provided to the team on internal TFL macros.
- Presented a poster presentation regarding few challenges faced while handling Socio-Economic Impact Questionnaire and action taken with help of statistician in an internal conference.
Confidential, Cincinnati OH
SAS Programmer
Responsibilities:
- Annotated CRF as per SDTM guidelines.
- Created specifications for SDTM and ADaM Mapping.
- Developed SDTM and ADaM datasets.
- Developed a Mock up Table according to clients need.
- Performed the tasks of designing and developing project-specific SAS programs like producing analysis datasets and reports.
- Analyzed datasets and generated statistical reports using SAS.
- Modified incoming data using SAS code by reformatting, importing, sorting, merging and restructuring.
Confidential
Jr. Statistical Programmer
Responsibilities:
- Data manipulation on SAS data sets using techniques such as merging, appending, concatenating and sorting.
- Created SDTM and ADaM datasets.
- Generated Tables & Listings.
- Produced outputs in different formats such as RTF and PDF using SAS/ODS.
Environment: SAS/BASE, WINDOWS and MS EXCEL