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Biostatistician Resume

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Rockville, MD

SUMMARY:

  • SAS programmer with 7 years of experience in data reporting in Clinical & Pharmaceutical industries with a strong background in science and research
  • Demonstrated analytical and problem solving skills in Information Management for clinical implementation requirements
  • Experience in preparation ofSASDatasets, Tables, Listings, Graphs (TLG’S), Reports, Output Delivery System (ODS) and Summaries according to Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP) and other requirements
  • Generating Safety and Efficacy tables, data listings and graphs
  • Experience in Design and reviewing CRF Experience in data validation
  • Experience in Integrated Summaries of Efficacy (ISE) and Safety (ISS) according to Statistical Analysis Plan (SAP) and Protocol
  • Expertise in transforming data imported from distinct data sources into analysis data structures, usingSAS functions, options, ODS, array processing, macro facility, and storing and managing data inSASdata files
  • Good knowledge ofClinicalTerminology and Regulatory Guidelines.
  • Extensive experience in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL
  • Experience in producing reports using various SAS procedures like Proc Print, Proc Report, Proc Tabulate, Proc Mean, Proc Freq, Proc Univariate, and Proc Transpose.
  • Performed Cleaning Techniques, QC Validation and Edit Checks as per protocol designs on Clinical Data.
  • Have knowledge in SAS programming, especially use of complicated Macros and PROC SQL
  • Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs.
  • Excellent organizational and communicational skills with high self - motivation.
  • Ability to understand job requirements, new methods, ideas, concepts, and technologies and take up challenges.

COMPUTER SKILLS:

  • SAS, including Base SAS, SAS MACRO, SAS SQL, and Report Procedure (Proc Report)
  • PASS (Also Gpower and P-S power and sample size solver)
  • JMP CRM Simulator
  • R - program
  • R-graphics, including TOURR, and GGPLOT
  • RedCap-Research Electronic Data Capture
  • Ingenuity Pathway Analysis (IPA) software
  • WEKA Data Mining software
  • CHEMCAD
  • Microsoft Office Suite, including Access, database management
  • MATLAB

PROFESSIONAL EXPERIENCE

Confidential, Rockville, MD

Biostatistician

Responsibilities:

  • Worked with clinical research staff and study group to provide SAS programming
  • Support for clinical trial projects
  • Assisted with analysis planning including review of table and listing mockups as well as dataset analysis as per requirements
  • Validated programming output with other programmers output and mockups in Statistical Analysis Plan
  • Used various procedures like PROC FREQ, PROC MEANS, PROC TABULATE, PROC SUMMARY and PROC REPORT to generate various data tables, patient data listings and reports according to Statistical Analysis Plan (SAP).
  • Contributed to Integrated Summary of Safety (ISS) analysis.
  • Created tables, graphs and listings (TGL’s) for inclusion in clinical study reports and regulatory submissions and also maintained existing ones by using SAS MACROS.
  • Ensured that analysis data and programming codes meet the regulatory and company standards and consistently structured to permit efficient programming and reporting.
  • Worked with biostatisticians to provide a detailed analysis plan from study protocols.
  • Wrote Customized Safety and Efficacy Reports directing SAS output to RTF and HTML files using Output Delivery System (ODS) facility.
  • Developed Data Validation E-Checks via SQL and created SAS Macros.
  • Performed simulations in R-program and SAS. For example, to find Confidence intervals, and dose escalation
  • Power and sample size calculations using PASS
  • Project required working in a SAS 9.3 Windows Environment, the ability to lead or work on several simultaneous projects or activities, knowledge of Data Management principles, a Broad understanding of Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs) & Standard Operating Procedures (SOPs), and interacting with other departmental colleagues, and line management.

Confidential, Morgantown, WV

Research Assistant

Responsibilities:

  • Database management, assisting in data collection and cleaning
  • Creating survey questionnaires using RedCap
  • Worked as a lead SAS programmer for different projects
  • Created SAS Programs for supporting the Statistical Analysis
  • Sample size and power calculation
  • Performed SAS Programming to verify the expected results and created Test Data from the input/output files.
  • Statistical analysis and abstract writing

\Confidential, Morgantown, WV

Department of Biostatistics

Responsibilities:

  • Database management
  • General consulting and statistical analysis for WV Clinical and Translational Science institute
  • Created Tables, Listings and Figures, data extraction, cleaning, and derivation of Derived datasets, Validation and documentation ofSAScodes
  • Responsible for manipulation ofclinicaltrials data usingSASin a Windows environment

Confidential, Morgantown, WV

Research Assistant

Responsibilities:

  • Database management
  • Generating descriptive plots
  • Statistical analysis
  • Manuscript writing
  • Experience working with high-dimensional biomedical data (e.g., microarray, genomic, or immune assay data)

Confidential

Research Specialist

Responsibilities:

  • Quality control and overseeing production during all drug developments
  • Maintaining large data sets i.e., reading data from various sources in various formats to createSASdata sets and/or ASCII files
  • Simulating and documenting the process i.e., Pilot testing for all the possible information using MATLAB and R-program
  • Developing macros for report generation usingSAS/Macros, SAS/SQL, and Proc Report
  • Involved in coordinating and planning multi-phase clinical drug trials to figure out the appropriate complexity, size and duration for testing
  • Reviewed and provided input to documents such as eCRF, analysis dataset and display specifications and QC record.
  • Performed statistical and data analysis, generated reports, graphs and listings using SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/SQL and SAS/ACCESS.
  • Worked with the Clinical Data Management Group to design and review database structures.
  • Integrated data from different studies and contributed in the preparation of Integrated Summary of Safety (ISS) for clinical studies.
  • Developed routine MACROS to create Tables, Listings and Figures (TLF’s)

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