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Skills

  • Bayesian statistics
  • Project coordination
  • Mentoring and training junior programmers
  • Budgets
  • Communications
  • MS Office
  • First Aid/CPR
  • Clinical Trial Data Analysis
  • Programming for FDA submissions
  • Usability understanding

Work Experiences

  • Metric and analytical data structures were designed and developed by me.
  • Automated reporting using SAS.
  • Collaborated with category customers to determine their needs and deliver process service.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Aided in decision-making.
  • Automated routine programming tasks.
  • Answered 12 calls per the past year to help customers with their questions and concerns.
  • Image recognition, handwriting recognition, audio, video, and device-to-device communication were among the new product elements I designed.
  • Centralized data into a data warehouse.
  • Achieved breakthrough insights.

Summaries

  • Data management professional with a passion for accuracy.
  • Within Miscellaneous, senior Statistical Programmer and outstanding performer in client relations and team leadership.
  • Consolidated data efficiently.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Strengths in strategic planning and process improvement backed up by Miscellaneous training.
  • Mandarin, Portuguese, and French development tools are among his specialties.
  • Capable of fostering a cooperative and supportive team environment.
  • Data-driven professional with expertise in assembling and cleaning large-scale clinical data sets, resulting in improved trial integrity and a Excellence Award for clinical data reporting excellence.
  • Created user-friendly visualizations using R Shiny.
  • Adept at managing and processing SDTM and ADaM datasets, possessing solid proficiency in CDISC compliance to ensure data quality and successful trial submissions.

Accomplishments

  • Launched advanced process automation in SAS, delivering 15% error reduction in routine data processing tasks across customer success.
  • Developed custom R Shiny applications that facilitated exploratory data analysis for non-technical stakeholders, making critical insights accessible to all teams.
  • Led the gap analysis project for compliance with CDISC ADaM and SDTM standards, resulting in a 54% reduction in data nonconformities.
  • Trained 2 junior programmers in advanced SAS techniques, resulting in their effective contribution to framework ahead of schedule.
  • Standardized output generation procedures across projects, ensuring consistent TLFs formatting for regulatory body compliance.
  • Implemented an efficient data management pipeline to support the large-scale processing of clinical trial data, reducing overall data preparation time by 60%.
  • Authored and revised statistical programming SOPs based on evolving regulatory guidelines, improving team adherence by 36%.
  • Functioned as the primary liaison to external CROs during project reviews, ensuring timely delivery of statistical programming outputs.
  • Built and tested complex regression models in SAS to examine clinical trial outcomes, contributing to method submissions.
  • Spearheaded a departmental initiative that optimized SAS/SQL database interactions, cutting query run-time by 20%.

Affiliations

  • Toastmasters
  • Active participant in the Clinical Data Interchange Standards Consortium (CDISC) webinars, gaining profound insights into transformations for SDTM and ADaM datasets.
  • Freemason
  • Graduate certification in Biostatistics from category, specializing in statistical methods for clinical trials and epidemiology.
  • Registered member of the Regulatory Affairs Professionals Society (RAPS), focusing on the intersection of statistical programming and regulatory compliance.
  • Certified in Advanced Predictive Modeling by Cedar Works, enhancing skills in machine learning applications for clinical trial outcomes.
  • Contributor to CDISC volunteer groups, participating in working groups to enhance clinical data standards for regulatory readiness.
  • National Association of Social Workers
  • Volunteer involvement in the Medidata Next User Group, collaborating on best practices in clinical trial data analysis tools.
  • Association for Computing Machinery

Certifications

  • Certified SAS Data Scientist by SAS Institute
  • SAS Advanced Programming Professional Certificate
  • Certified Public Accountant
  • SAS Certified Statistical Business Analyst Using SAS 9: Regression and Modeling
  • RStudio Certification for Data Science and Big Data Programming
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Clinical Data Manager (CCDM) from Vantage
  • Biostaticals Planning and Analysis certification by Meridian
  • SAS Certified Advanced Programmer for SAS 9
  • First Aid/CPR Certified

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