SUMMARY

• Experienced SAS Certified programmer with several years of experience working in various clinical trials including analysis, reporting, macro development, testing and implementation of various projects for Pharmaceutical and CRO .
• Experience in working on Phase II - IV of Clinical trials including Statistical Analysis. Good understanding of drug development process.
• Familiarity with Medical dictionaries like MedDRA & WHODrug.
• Good understanding of the Protocol, Annotated CRF, raw data, SDTM and Analysis datasets for all studies assigned.
• Experience in SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/ODS & SAS/GRAPH in both UNIX and Windows environment.
• Experience in development & validation of statistical TLFs, ad-hoc reporting Confidential t profile listings and analysis data set programs of both Safety and Efficacy.
• Good understanding of 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.
• Experience in participating staff, data/operations, Clinical project team and study-level meetings for multiple projects.
• Excellent interpersonal and communication skills, highly dedicated, quick starter, solution driven pattern programmer, Design and excellent at solving complex problems under strict deadlines.

TECHNICAL SKILLS

SAS SKILLS: SAS/BASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS V6.12, V8, V9.1.2;

DATABASE PLATFORMS: Oracle Clinical, SQL, Oracle 8i/9i;

OPERATING SYSTEMS: Windows 98/XP/2000, Open VMS;

DESIGN TOOLS: MS Office 97/2000/XP, MS Excel, Power Point, MS Word;

LANGUAGES: Oracle 9i.

PROFESSIONAL EXPERIENCE

Sr SAS Programmer/Analyst

Confidential, East Hanover, NJ

Responsibilities:

• Experience in generating SDTM data, writing specifications for ADaM and generating ADaM datasets following CDISC standards. Generated SDTM data for domains like AE, DM, VS, EX, CM, MH, LB
• Experience in safety and efficacy statistical analysis of multiple therapeutic area studies. Perform data integrations for generating summary of safety and efficacy.
• Generated safety summary table, descriptive tables, efficacy tables and created reports by using output like RTF, PDF and HTML.
• Created SDTM datasets (version 3.2 ) for Lab, Adverse Events, and Demography from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.
• Extensively used various procedures like proc means, proc univariate, proc freq, proc report, proc summary, proc gplot, proc sql etc
• Proficient in indicating the input data sets, sorting and merging, transposing Techniques to get the required report.
• Execute analyses specified in the Statistical Analysis Plan (SAP) under the guidance of the project statistician and other analysis supporting ad hoc requests.
• Produce special reports to comply with regulatory requests. Use SAS ODS in combination with PROC Template to generate reports and use GTL, ODS and SG procedures for creating graphs.
• Extensive work on CDISC ISS, integrating different study protocols for the analysis of drug effects on subjects.
• Developed specifications for database in CDISC format and involved in programming datasets in CDISC STDM model 3.1 and managed CDISC database for several studies.
• Write specifications to create CDISC compliant pooled Analysis data sets.
• Program datasets in SDTM and ADaM data formats following the CDISC data standards.
• Extensively worked on creating Population, Adverse Events, and Concomitant Medication data sets.
• Created Tables, Listings and Graphs as per the tables, listings and Graph shells provided by the lead statistician and involved in validation for TLGs.
• Experience using Printer Control Language for generating the tables and listings by batch processing.
• Involved in developing specification for data sets based on STDM and ADaM standards.
• QC of Analysis datasets programmed by other programmers by parallel programming using raw data.

Environment: SAS/BASE, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/SQL, SAS/ACCESS, SAS/CONNECT

Sr. SAS Programmer/Analyst

Confidential - Rockville, MD

Responsibilities:

• Generated and validated tables, listings and graphs for clinical studies and adhoc analysis for PI - PIV oncology studies
• Create DDS for SDTM/ADaM datasets and create respective datasets (using Protocol, IG, Data Specs)
• Lead programmer a team of 3 programmers for Phase III study
• Program supplemental & custom domains according to CRF mapping
• Develop the required expertise in all SAS PROCs that are needed to generate the analyses.
• Generated ISS
• Create outputs using ODS option into formats (RTF, PDF, Excel)
• Cross-validated SAS programs authored by other SAS programmers as QC
• Reviewed documents including protocol, CRF, SAP, mock-up shell
• Mapped raw data variables and defined specifications for derived datasets
• Programmed & validated analysis datasets, TLFs, ad hoc reports, and Mock Shells as per SAP
• Developed local macros for repetitive processing of parameters to improve efficiency
• Good working knowledge of CDISC SDTM Implementation Guidelines and ADaM
• Collaborated with Biostatisticians & Data Management on current studies

Sr. SAS Programmer/Analyst

Confidential, Princeton, NJ

Responsibilities:

• Serve as the statistical programming lead on internal project teams and coordinates programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures
• Manage and/or mentor junior level statistical programming staff.
• Identify project priorities and project timeline goals and communicate priority - related issues and timelines to programming teams
• Ensure the efficiency, quality, and integrity of data reporting, and project activities executed
• Successfully represent the department and the company in client meetings/presentations and maintain a positive working relationship with sponsors, collaborating associates, and vendor personnel
• Perform other duties as assigned
• Technical knowledge of CDISC SDTM model.
• Develop SAS programs to produce statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP).
• Develop SAS programs to produce integrated analyses and tables for the summary sections of New Drug Applications (NDAs) including ISS and ISE.
• Develop specifications (metadata files) and create SAS programs for the mapping of raw datasets to CDISC SDTM standards. Create define.xml files from metadata files
• Develop SAS programs to produce analysis datasets in CDISC ADaM or other formats specified by the sponsor.
• Design and implement quality control (QC) programs to ensure the quality and integrity of statistical programs which are used to generate datasets including CDISC SDTM and ADaM datasets.
• Is aware of timelines and scope based on resourcing / priority constraints within the programming team and understand the implications on individual work assignments
• Builds and maintains effective working relationships with programming team members
• Function as Lead Programmer on one or more clinical trials:
• Set up the study-level programming environment
• Provide project deliverable oversight, guidance and direction to the programming team.
• Provide guidance in programming for complex analysis tables/figures, appropriate procedure/method selection for advance statistical analyses
• Ensure all programming activities on the study adhere to required standards
• Provide input to and participate in intra-departmental meetings
• Work closely with the client and SCRI project statisticians to ensure that all project milestones are communicated, tracked, and delivered within agreed upon planned timelines
• Provide support to and mentor more junior programmer
• Participate in the recruitment of programming staff and contractors
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to programming teams and the Statistical Programming department
• Manage project budget and resource requirements
• Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision
• Contribute to the continuous improvement of Data Science (DS) and programming.
• Assist in the review of DS policies, standard operating procedures and other controlled documents
• Promote and communicate awareness of Statistical programming and the role of the DS department in internal and external professional organizations, conferences, training, or meetings
• Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget
• Communicates effectively not only within the teams and functional lines but also with external resources
• Assists with other duties as assigned
• Carry out all activities according to SCRI SOPs working within the framework of the Quality
• Management System and to Good Clinical Practice (GCP)
• Adapts to changing circumstances, policies, work assignments, and/or team members. Able to multi-task and prioritize between tasks
• Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment
• Develop good problem solving skills and a willingness to learn and seek advice from management.

Sr. SAS programmer

Confidential, Durham, NC

Responsibilities:

• Created Analysis Datasets, Summary Tables, Listings and Figures according to the specification of the study for statistical analysis.
• Developed specs for Analysis Datasets.
• Involved in QC of Analysis Datasets, Summary Tables, Listings and Figures.
• Modified the datasets according to the requirements of the statistician. Data validation and quality control check of the displays and datasets according to the different QC levels.
• Investigate, prepare, analyze, and validate data for down streaming Modeling and Analysis. Trained in Good Clinical Practice (GCP), Regulatory Compliance and FDA Guidelines.
• Extensively worked on PROC REPORT to produce reports for the purpose of validation.
• Involved in writing code using data step programming and macros to extract, clean and validate date from external source.
• Extensively worked with complex and huge datasets, and generated reports in various formats such as PDF and list files using SAS ODS facility.
• Validating the datasets and comparing the results to that of source programmers output.
• Attended project team meetings, interacted with Bio -Statisticians, Data Managers, and Clinical Research Managers.

SAS Programmer

Confidential, Burlingame, CA

Responsibilities:

• Involved in the support of Phase II- III clinical trials.
• Responsible for developing the SAS programs following the information stated in Statistical Analysis Plan (SAP).
• Created datasets in CDISC SDTM V 3.1.2 format, based on CDISC SDTM implementation guide Wrote statistical programs for analyses datasets, tables and listings for clinical study reports.
• Created ad hoc programs to provide information to the project team and/or client, as required.
• Performed Statistical Analysis and generated reports using SAS/MACRO, SAS/ODS, Proc Report, Proc Print, Proc Summary, Proc Freq, Proc means, Proc tabulate and Proc SQL.
• Performed validation of SAS-generated output (tables, listings and graphs) via independent programming. Also performed QC check.
• Imported data in the form of SAS datasets from flat files of various formats like pipe delimited, tab delimited, .CSV, .XPT etc.
• Used SDTM guidelines to create various data domains according to CDISC standards. Developed Macros to generate ad hoc reports weekly, monthly or on a specified cut date.
• Handled ECG, LAB, PK data imported from various vendors to merge it with the CRF data and reported any inconsistencies in this data to the CDM to be resolved.
• Exported data to various clients in the form of SAS Transport files over secure servers or on electronic media on regular basis.
• Responsible for producing post-text tables, in-text tables, selected Confidential t listings and lab tables, Wrote edit check programs using Oracle, PL/SQL for data validation before using for final analysis.