SUMMARY:

• SAS Certified Advanced Programmer with 9+ Years of functional and technical experience in Pharmaceutical and CRO industry.
• Proficiency in understanding of Study Protocols, SAP, CRF and other study documents.
• Experience in therapeutic areas of Oncology, Respiratory, Cardiovascular Disease, Gastrointestinal.
• Thorough knowledge of Clinical Trials data like Demographic, Adverse Events, Laboratory, Vital Signs and Efficacy etc.
• Strong experience of CDISC standards. PreparedSDTMand ADaM data sets as per CDISC standards.
• Expertise in analyzing clinical trial data and generated Tables, Listings, Figures (TLF) as per Statistical Analysis Plan (SAP), Standard Operating Procedures (SOP) and also performed validation of the SDTM, ADaM datasets and TLF’s.
• Expertise in using SAS report procedures like PROC REPORT, PROC SQL, PROC TRANSPOSE, PROC SUMMARY and experience in Statistical Analysis using SAS/STAT Procedures such as PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC LIFETEST, PROC TTEST and other leaner models like PROC MIXED, ANOVA, ANCOVA, PROC REGRESSION, .
• Hands on experience in writing and reviewing programming specifications for safety SDTM datasets, ADaM datasets based on SAP, CRF, and studies.
• Experience in creating new SAS programs using SAS MACRO to improve ease and speed of modifications as well as consistency of results.
• Trained on RECIST 1.1 standards for confirming responses and hands on experience generated subjects RECIST Tumor response listings.
• Strong work experience in preparing Trial design datasets (TA, TE, TV, TI, TS) for complex study designs with CDISC SDTM standards.
• Work experience in using Open CDISC Validation tool/Pinnacle 21 for SDTM dataset validation and preparing the reviewers guide document for study specific warning messages.
• Hands on experience in preparing Confidential t narratives as per the sponsor specification.
• Hands on experience in creating ANCNAE / SMQs (Standard MeDRA Queries) dataset using CRS (Case Retrieval Sheet) document and generating SMQ/AE reports.
• Good experience in working collaboratively with GPL (Global programming lead)/Sr. Statistical Programmer in developing complex dataset Laboratory, Exposure and other Efficacy datasets and Reports.
• Experience in working on multiple protocols and/or drug compounds at the same time and Worked as Individual contributor/ Team member/ Lead programmer and allocating the work for team members and follow up them to achieve the timelines.
• Overseeing all the programming activities for internal team and coordinating among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS).
• Quick learner and excellent team player, consistently meeting study timelines and can work in critical situations.

TECHNICAL SKILLS:

Statistical Software: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/Access, SAS/EG, SAS/STAT, SAS/Access, SAS/CONNECT, SAS/ODS

Database: Oracle, MS Access, SQL.

Operating Systems: UNIX, Windows.

PROFESSIONAL EXPERIENCE:

Sr. Statistical Programmer

Confidential, NJ

• Develop programs to generate listings and summary tables for Clinical Study Reports as described in the Statistical Analysis Plan.
• Converted large raw data files into SDTM datasets according to CDISC Standards.
• Created ADaM datasets based on the ADaM Implementation guide
• Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDISC format with minimal instruction or input from supervisor
• Generated reports for ad - hoc analysis for the investigator brochure and the medical team.
• Efficiently utilized macros to eliminate repetitive SAS codes.
• Responsible for validating data imports from various data vendors and generated reconciliation reports for DM teams and creating general transformations and extracts from data imports.
• Involved in testing, development and validation of company standard utility macros.
• Coordinated with project manager and statisticians in setting up Study area, and maintaining budget and resources, internal deliverable timelines.
• Quality check and documentation of outbound files and packaged deliverables to the client as Company SOPs. Created process documents and maintained data validation forms to ensure secure file transfers to various clients.
• Proven skills in data validation, debugging and documenting SAS programs.
• Mentored and trained junior programmers and new hires in understanding various company SOPs, study and client specific standards.
• Responsible for creating format libraries for different studies.
• Worked closely with Statistician in finalizing the Table specs.
• Table Programming for Integrated Summary of Safety (ISS).
• Performed Data Validation and Data cleaning of the clinical trial data.
• Generated define.pdf using company specific tools at the end of data base lock.

Statistical Programmer

Confidential, NJ

• Understanding the Protocol, CRF, SAP, Mock shell.
• Involved in the development of the CDISC standardSDTM and ADaM domains as per programming specification.
• Experience in creating TLFs using SAS programming as per the SAP/TLF shells.
• Involved in reviewing, providing comments and updating programming specification documents for SDTM, ADaM datasets.
• Worked for several ad-hoc reports for safety and efficacy as per the Specifications that were provided by the Statisticians.
• Was involved in validation of outputs and datasets using procedures like PROC COMPARE and PROC FREQ, PROC MEANS, PROC SQL… Etc.
• Validated statistical outputs: verifying frequencies using PROC SQL, confidence intervals using PROC UNIVARIATE, Kaplan Meier estimates using PROC LIFETEST.
• Involved in updating reusable Macros as per the study requirement.
• Formatted RTF and PDF reports using SAS output delivery system.
• Attended project Weekly/Monthly team meetings to update the study work status and clarification of study concerns, worked with Bio-Statisticians, Data Managers, and Clinical ResearchManagers as appropriate.
• Involved in Dry-run, DBL and Clinical Study Reports (CSR) activities like production run and submitting Tables, Listings and Figures.
• Overseeing all the programming activities for internal team and coordinating among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS).

Statistical Programmer

Confidential

• Responsible for providing SAS programming and analysis support for phase III clinical study.
• Creating non-standard macros for the generation of Datasets, Tables and Listings.
• Conducting extensive statistical analysis using Base SAS and SAS/STAT.
• Mapping and integrating external study data to a CDISC-compliant proprietary analysis data system (SDTM).
• Involved in Validation of Datasets, Tables and Listings created by fellow programmers.
• Perform program documentation on all programs, files and variables for future .
• Interacted with statistician and clinical people for creating reports.
• Used SAS Macros extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
• Created several adhoc reports using SAS.
• Developed new SAS programs and modified existing SAS programs. Performed ad-hoc programming as per requests.
• Responsible for providing proper validation, including testing and documentation in accordance with company standards
• Contributed to Case Study Reports (CSR) and documentation for FDA submission.
• Responsible for validating data imports from various data vendors and generated reconciliation reports for DM teams and creating general transformations and extracts from data imports.
• Involved in testing, development and validation of company standard utility macros.

Clinical SAS Programmer

Confidential

• Performed SAS Edit Checks on the raw SAS data sets.
• Created various CDISC standard SDTM domains from raw data as per Programming specification.
• Developed SAS code for report generation.
• Ensured that all SAS programs are imported into the archive system prior to the creation of final output.
• Ensured all programs are formally archived after the completion of the regulated activity.
• Involved in the review of the SDTM programming specification created by client programmer/ Sr Statistical programmer provided comments on the same.
• Review for consistency across studies within a project.
• Used the SAS procedures PROC MEANS, FREQ, SUMMARY, REPORT for summarization and statistical analysis purposes.
• Involved in the Qc of the SAS-generated output and datasets
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML.