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Skills

  • Team management
  • Regulatory compliance
  • Organization
  • Clinical trial statistical analysis
  • Knowledge of ICH-GCP guidelines
  • Rare disease clinical trial methodologies
  • Data preparation and cleaning
  • Covariate adjustment in clinical trials
  • Power and sample size calculations
  • Project management methodologies in clinical settings

Work Experiences

  • Collaborated with stakeholders.
  • Collaborated with multidisciplinary teams, including data managers and epidemiologists, to develop SAP models which accelerated project completion by 3 months.
  • Completed within the last several months.
  • Accelerated project completion by 17 months.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Oversaw the delivery of method project by system team, which resulted in standard.
  • Authored peer-reviewed articles.
  • Authored and oversaw the execution of 12 data safety and monitoring board (DSMB) reports for high-risk clinical studies ensuring regulatory and ethical compliance.
  • Authored and co-authored peer-reviewed articles that contributed to over 13-citations in highly-regarded scientific journals.
  • Achieved 36% accuracy improvement.

Summaries

  • Authored 14 statistical analysis plans (SAPs).
  • Accelerated trial outcomes.
  • Boosted forecast accuracy by 17%.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Accomplished in regulatory compliance.
  • Senior Biostatistician with process improvement and team leadership expertise.
  • Achieved on-site visit reductions of 36%.
  • Professional with excellent verbal and written communication skills who is self-assured and structured.
  • Authored and co-authored a total of 2 journal entries.
  • Accomplished Senior Biostatistician with over 9 years of experience.

Accomplishments

  • Designed adaptive trial models that enabled protocol flexibility and faster decision-making by the clinical team.
  • Collaborated with cross-functional teams to design and implement a novel risk management strategy, leading to improved patient safety outcomes.
  • Resolved product issue through consumer testing.
  • Applied rigorous missing data handling techniques that increased the reliability of clinical trial results by 40%.
  • Applied advanced survival analysis techniques, reducing prediction errors in patient survival outcomes by 57%.
  • Trained and mentored 8 junior statisticians in advanced statistical methodologies, boosting overall team competency by 32%.
  • Developed customized Bayesian models that enhanced predictive accuracy in long-term treatment studies.
  • Managed statistical aspects of multi-site clinical trials involving 6 patients across 14 locations, ensuring high data quality and compliance.
  • Documented and resolved program which led to category.
  • Co-authored peer-reviewed publications on patient-reported outcomes, gaining recognition in the field and receiving Innovation Award.

Affiliations

  • Affiliation with the Drug Information Association (DIA)
  • Collaborator with the American Heart Association (AHA) on clinical trial designs
  • Association of Information Technology Professionals
  • Member of the International Biometric Society (IBS)
  • Co-chair of the Data Safety Monitoring Board (DSMB) for initiative
  • National Association of Social Workers
  • Lions Club
  • International Association of Administrative Professionals
  • Collaborator in the Collaborative for Research in Biostatistics (CRB)
  • Certification through the Society for Clinical Data Management (SCDM)

Certifications

  • Health Economics and Outcomes Research (HEOR) Certification — standard
  • Pharmaceutical Biostatistics Certification — initiative
  • Certified Professional in Healthcare Quality (CPHQ) – National Association for Healthcare Quality
  • Certified Regulatory Affairs Professional (RAC) — metric
  • Cisco Certified Internetwork Expert (CCIE)
  • Ethical Issues in Data Research Certification — method
  • Certified CRA (Clinical Research Associate) — system
  • Clinical Research Coordinator Certification (CCRC) — initiative
  • Certified Clinical Data Manager (CCDM) - category
  • ICH-GCP (International Council for Harmonisation - Good Clinical Practice) Certification — program

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