OBJECTIVE

• Seeking a senior SAS Programmer in Pharmaceutical Industry Company or CRO.

SUMMARY

• About 7 years of professional experience on SAS programming and statistical analysis in CRO and Pharmaceutical Companies.
• Understand the drug development procedures, CRF, SAPs, CDISC standards, MedDRA, WHODRUG, Industry SOPs and FDA submission guidelines very well.
• Understand of clinical data structures Thoroughly.
• Convert all kinds of external data to SAS data sets.
• Perform statistical analysis of clinical trial phase II, III and IV by using SAS.
• Experience at NDA/ANDA submission, NMPA Submission, PMDA Submission, EMEA submission.
• Proficient in analysis of Clinical Trial data and preparation of SAS datasets, TLFs and reports.
• Contribute to the maintenance of Macros and creation of Macros for different purposes in multiple studies.
• Contributed to the Integrated Summary of Safety and Efficacy (ISS/ISE).
• Checked the operations in organization meet regulatory standards.
• Proficient in reviewing, debugging, and validating SAS programs.
• Experience inClinicalData Interchange Standards Consortium (CDISC) process related to data standards including Study Data Tabulation Model (SDTM) and Analysis Dataset Models (ADaM).
• Experience in the QC (quality control) of Derived ADaM datasets, SDTM datasets.
• Good at mapping specifications for SDTM domains.
• Familiar with SDTM domains such as DM, AE, LB, TU, TR, RS etc.
• Familiar with ADaM data such as ADSL, ADAE, ADTR, ADRS, ADTTE etc.
• Familiar with annotation of CRF in SDTM and Mapping Specifications for SDTM.
• Handle ad - hoc requests from FDA or Professional Meeting
• Experimental design, Hypothesis Testing
• Multivariate Analysis: one-way ANOVA / two-way ANOVA (PROC GLM).
• Time Series Analysis, Regression Model, Mixed effects Models.
• Fisher test / chi-square test (PROC FREQ), Logistic regression (PROC LOGISTIC)
• Survival Analysis (PROC LIFETEST, PROC PHREG)
• Good organization, time management and attention to detail. Can work in a stressful environment under tight deadlines while maintaining focus on details and quality.

TECHNICAL SKILLS

• SAS/SQL
• SAS/MACRO
• SAS/STAT
• SAS/BASE
• R
• Microsoft SQL Server
• Python
• Minitab.
• Windows
• Linux

PROFESSIONAL EXPERIENCE

Senior SAS programmer

Confidential

Responsibilities:

• Involve in analyzing Clinical Trails data for Phase II and Phase III process in Oncology therapies area.
• Collaborate with statisticians to review Statistical Analysis Plan (SAP), Protocol, TFL mock shells, CRF, Clinical Study Reports (CSR), Data Management Plan (DMP), Data Specifications and Mapping Specifications for individual studies and ISS/ISE (Integrated Summary for Safety/Efficacy) for pooled studies
• Convert data received in other formats to SAS data sets.
• Contribute to the development and documentation of mapping specifications, safety, and efficacy analysis programming.
• Review the annotated SDTM CRF to meet CDISC standards.
• Develop standardized and Customized ADaM domain datasets, including ADSL, ADTR, ADRS, ADTTE etc.
• Generate analysis data sets, tables, figures, and listings to support the analysis of clinical trials data.
• Assist in programming electronic submission deliverables.
• Used SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
• To meet ad-hoc programming requests.
• Modify existing Macros and create new Macros for different purposes in multiple studies.
• Produce CDISC SDTM/ADaM specifications for Efficacy and Safety related domains for different therapeutic areas.
• Generate derived data sets (ADaM) for demographics (ADSL), Tumour Results (ADTR), Tumor Response Analysis (ADRS), Time to Event (ADTTE) etc.
• Map clinical data to SDTM/ADaM and validation.
• Perform the Data Integrations/Pooling from multiple studies and develop/validate the CSR output for ISS/ISE
• Attend meetings with SAS Programmer, Data Manager, Statistician etc.

Senior SAS Programmer

Confidential, Basking Ridge, NJ

Responsibilities:

• Worked mainly on Phases II and III of clinical trials for therapy area such as Oncology, Diabetes and Cardiovascular
• Performed analysis of safety and efficacy in Phase II and Phase III.
• Performed Validation or Quality Control over CDISC/SDTM data sets
• Checked the Compliance of SDTM/ADaM by Pinnacle 21, CDISC, and company customized check list and update SDTM/ADaM correspondingly
• Produced CDISC SDTM domains (DM, AE, LB, EX, TU, TR etc.)
• Generated SAPs for clinical trials, and developed table /Mock shells for Phase I studies
• Performed data integration for pooling from multiple studies across different phases and statistical analysis output for ISS/ISE integrated studies
• Created reusable and complex SAS macros to increase the efficiency, consistency and accuracy of statistical output and complex data manipulation
• Prepared Transport (xpt) files and define.xml etc. for regulatory submission
• Worked on Quality Control procedures and Quality Assurance for mapping and Clinical Study Report program.
• Participated in NDA submission.
• Developed RTF, HTML, and PDF reports for CSR by using SAS ODS.
• Processed dynamic and efficient SAS programs using SAS Tools, such as SAS/Base, SAS/Macros, SAS/SQL, and SAS/STAT.

Statistical Programmer

Confidential, Philadelphia, PA

Responsibilities:

• Generated tables, listings, and graphs for FDA submissions
• Produced CDISC SDTM domains (DM, AE etc.) for Phase II and III studies.
• Developed validation programs for Clinical data.
• Managed macros for initialization and statistical analysis and for generating multiple graphs per page and output as word document.
• Used Macro libraries routinely in many SAS programs.
• Imported and exported data from other data sources such as Excel, Access.
• Performed data validation, quality review of programs coded by other programmers and checked for data consistency.
• Annotated and reviewed Case Report Forms (CRFs)
• Created reports using ODS in various file formats such as RTF, LISTING.
• Developed reports using MEANS, FREQ, REPORT, UNIVARIATE and SQL