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AMY SMITH
123 Main Street Atlanta, Georgia 30339
Home: (555) 555-1234, Cell: (555) 555-1235 asmith@sample~resume.com


Seek the position of Associate Director of Biostatistical Programming in a major Pharmaceutical Company
A highly gifted Statistician with over 12 years of experience in putting mathematics to scientific use in the form of data comparison, analysis, and presentation to design, collect, and interpret data experiments surrounding the field of medicine. A renowned expert with proven ability in research and product development.

Core Competencies
  • Advanced knowledge of statistical methods routinely used in clinical trials.
  • Advanced knowledge of processes for planning, conducting, data processing, analysis and reporting of clinical trials.
  • Proficient use of statistical analysis software (SAS).
  • Superb understanding of drug development processes.
  • Great oral and written communication skills.
  • Solid knowledge of FDA and ICH regulations applicable to the design, analysis and reporting of clinical trials.
  • Profound ability to identify measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
  • Ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
  • Uncommon ability to select and use training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
  • Expert in using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Solid understanding of the implications of new information for both current and future problem-solving and decision-making.
  • Immense working knowledge of major statistical software package (Splus, SAS and Stata) and experience in computing in both Windows and UNIX environment.
PROFESSIONAL EXPERIENCE

AirMAS Pharm, Inc., New York                     2000 - Present
Senior Statistician
  1. Provide statistical expertise to design clinical trials, define and execute analyses and interpret statistical results.
  2. Define analysis endpoints, statistical methodology and sample size for clinical trials.
  3. Efficiently provide accurate, statistically appropriate outputs included in protocols, statistical analysis plans, study reports and regulatory submission documents.
  4. Plan and direct study-level statistics activities including work of other statisticians, programmers and contract research organizations (CROs).
  5. Confirm accuracy of statistical outputs produced by CROs.
  6. Provide timely, high-quality review of clinical trial documents (e.g., protocols, case report forms, study reports) and outsourcing documents (e.g., proposals, task orders and change orders).
  7. Provide statistical input to drug development and submission plans.
  8. Contribute to definition of strategies to address statistical questions from regulatory authorities.
  9. Contribute to definition of project level database, analysis and reporting standards.
  10. Comply with all applicable regulatory requirements and Takeda standards and procedures.
GoldHealth Inc., New York                             1996 - 2000
Statistician
  1. Developed close working relationships with other members of the Statistics team.
  2. Assisted with problem solving and the provision of statistical support across UK Operations.
  3. Performed quality data analysis using relevant tools and techniques.
  4. Coached and supported others in the use of Statistics.
Gold University, New York                              1993 - 1996
Biostatistician
  1. Research on product development.
Education and Professional Development

University of New York, Ph.D. in Statistics, 2000
University of New York, MS in mathematics, 1995
University of New York, BS in mathematics, 1992



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