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Skills

  • Phase I-IV clinical trial data analysis
  • Gap analysis for data submission completeness
  • Automating statistical processes using SAS macros
  • Communications
  • Data mining
  • Developing test scripts for data validation
  • Data analysis
  • Advanced SAS programming
  • Organization
  • Software programming

Work Experiences

  • Evaluated statistical techniques and extracted process information from research data to provide different ways to assess the robustness of research outputs.
  • Automated reporting processes.
  • Achieved milestone deadlines.
  • Transported QuickBooks to three years customer locations.
  • Championed the implementation of standardized analysis datasets (ADaM), reducing FDA query responses by 79%.
  • Solved system issues, improved operations, and provided excellent customer service.
  • Performed data quality checks and data cleaning activities on data sources to look for inconsistencies.
  • Advocated and implemented robust QC methodologies, improving compliance with regulatory standards by 29%.
  • Achieved results over one year.
  • Coordinated statistical activities and created, maintained, and updated data dictionaries and coding guides for 17 projects.

Summaries

  • Achieved 2 successful regulatory submissions.
  • Clear understanding of cross-functional collaboration and performance reporting as well as cross-functional collaboration training.
  • Within Miscellaneous, senior Senior Statistical Programmer and outstanding performer in team leadership and performance reporting.
  • Contributed to streamlined workflows.
  • Experienced in creating reports from complex data.
  • A forward-thinking senior programmer with a passion for data accuracy and compliance, known for creating and automating reports to cut project timelines by 48%.
  • Strengths in assessing data reliability and producing meaningful reports are well-known.
  • Technical writing and documentation are areas in which I excel.
  • Adept at collaborating with cross-functional teams.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.

Accomplishments

  • Developed and implemented advanced algorithms to model patient outcomes for process, which improved trial predictions and reduced necessary subject enrollment by 83%.
  • Presented real-time data insights for an QuickBooks clinical trial, enabling data-driven decisions that resulted in a framework% faster time-to-market.
  • Automated the validation process for key statistical reports, reducing manual efforts by 71% and ensuring 100% regulatory compliance.
  • Led the development of SOPs for the statistical programming department, resulting in fully standardized processes that reduced setup time by 62%.
  • Created standardized datasets and procedures that reduced runtime for batch statistical analyses by 60%.
  • Documented and resolved procedure which led to program.
  • Presented integrated data visualizations to cross-functional teams, facilitating key insights that led to a $18 revenue increase for a ServiceNow launch.
  • Coordinated across functional teams to develop predictive models used in standard development, which boosted project efficiency and reduced analysis time by 70%.
  • Resolved product issue through consumer testing.
  • Mentored 18 junior programmers, who subsequently earned Six Sigma and contributed to a 24% improvement in data cleaning and preparation procedures.

Affiliations

  • Association for Computing Machinery
  • International Society of Pharmacovigilance (ISoP)
  • Association of Information Technology Professionals
  • International Society for Clinical Biostatistics (ISCB)
  • American Statistical Association (ASA)
  • Toastmasters
  • Association for Supply Chain Management (APICS)
  • Project Management Institute
  • American Association of Pharmaceutical Scientists (AAPS)
  • Biostatistics Section of the American Public Health Association (APHA)

Certifications

  • SAS Advanced Analytics Professional Certification from SAS Institute
  • CompTIA Network+
  • Certified Public Accountant (CPA)
  • Google Certified Professional Cloud Architect
  • Project Management Professional (PMP)
  • Certified Public Accountant
  • Certified Advance Health Informatics Specialist from HIMSS
  • SAS Certified Clinical Trials Programmer Using SAS 9
  • Certified Health Data Analyst (CHDA) from AHIMA
  • SAS Certified Specialist: Base Programming Using SAS 9.4

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