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Statistician Resume Example

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JC
Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Professional Overview
  • Two years of pharmaceutical (CRO) experience; skilled in phase I to phase IV clinical trials in therapeutic areas of CNS, Oncology, Hematology Insomnia and PK/PD.
  • Worked in environment with controlled documents such as SOPs, ICH/FDA guidelines and study protocols.
  • Excellent skills in SQL, SAS Macro Facility, SAS/GRAPH, SAS/STAT/SPSS.
  • Providing sample calculations, randomization schemes and appropriate documentation.
  • Developing statistical analysis plan, including table and listing specification, generating and validating SDTM, ADaMs, data listings and tables for individual studies and ISS/ISE for CDISC-compliant data submission.
  • Excellent interpersonal and communication skills with good team player attitude.
  • Work well within a team and independently with minimal supervision.
Core Qualifications
  • Excellent skills in SQL, SAS Macro Facility, SAS/GRAPH, SAS/STAT/SPSS
  • Effective communicator
  • Expert in Phase I to IV study
  • Multi-Task Management
  • Excellent interpersonal and communication skills with good team player attitude
Accomplishments
  • Preparation of statistical analysis plans including mock up tables
  • Application of statistical section of clinical trial reports
  • Review of protocols/case report forms/statistical analysis plans/clinical trial reports
  • Have thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development.
  • In charge of 2 phase I and 2 phase III study NDA submission tasks to ensure high quality deliverables that comply regulatory electronic submission guidance
Education
Expected in June 2012 B.A | Mathematics East China Normal University, Columbia, Shanghai GPA:

Economics Skilled in Statistical/Mathematical analysis

Expected in Dec 2013 M.A | Statistics University of Missouri, Columbia, Missouri GPA:

Coursework in Statistics and Mathematics

Experience
11/2014 to Current Statistician Department Of Energy | Kansas City, MO,

• Solid knowledge of SAS and familiarity with other statistical software packages.

• Participation in randomization development and validation process.

• Preparation of statistical analysis plans including mock up tables.

• Application of statistical methods and analysis of clinical study data.

• Preparation of statistical section of clinical trial reports.

• Review of protocols/case report forms/statistical analysis plans/clinical trial reports.

• Have thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development. Have the ability to identify, evaluate and implement as needed innovative statistical methods to provide added value to the company drug development process.

• In charge of 2 phase I and 2 phase III studies NDA submission tasks to ensure high quality deliverables that comply with regulatory electronic submission guidance:

  • Developed the statistical model specs for primary efficacy analysis including repeat measures model, survival analysis and time to event.
  • Creation and QC of mapping specification and data definition tables (define.xml, define.pdf) for Study Data Tabulation Model (SDTMs) and Analysis Data Model (ADaMs)
  • Finalized SDTMs and ADaMs deliverables and ensured all documents following CDISC implementation guideline in Submission datasets
  • QC of ADaMs against table, listing and figure shell in corresponding CSR and CRF sections to ensure that submission dataset section supports other clinical submission sections
  • Used standard SAS programs or write ad hoc SAS programs for creating, checking submission content
  • Investigated, evaluated and proposed the use of emerging publishing technologies for use in preparation of dataset section of submission

2014 to 11/2014 Associate Statistician, Biostatistics Benefitfocus | Reno, NV,
  • Assist the Biostatistician (or above) to participate in randomization development for clinical trials.
  • Assist the Biostatistician (or above) to prepare statistical analysis plans and table shells.
  • Application of statistical methods and analysis of clinical trial data, employing SAS statistical software.
  • Assist the Biostatistician (or above) to prepare the statistical section of clinical trial reports.
  • Review of clinical trial protocols/case report forms/statistical analysis plans/clinical trial reports Develop thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development.
  • Develop the ability to identify, evaluate and implement innovative statistical methods as needed to provide added value to H2O Clinical and client drug development process.
07/2013 to 11/2013 Consultant Enchantment Resort | Scottsdale, AZ,
  • Collaborated with biomedical researchers and consult on statistical analysis and reporting design for research project.
  • Develops descriptive statistic and exploratory statistical analysis for Principle Investigator using SAS and SPSS.
  • Design the questionnaire and clean the collected data Convert and quantified research questions into statistical objectives.
  • Supported the educational goals and objectives by designing, analyzing, and reporting statistical outcomes.
  • Explain the models and interpret the results of statistical models.
  • Write the final statistical report and present the outcome to the clients.
04/2010 to 11/2010 Team Leader East China Normal University | City, STATE,
  • Design the questionnaire and algorithm.
  • Build model and programming by using Matlab and C++.
  • Write the final report and outcome.
Fellowships and Awards
  • Volunteers’ team leader for 2010 Shanghai Expo 2010
  • Second Prize in National Undergraduate Mathematical Contest in Modeling 2009
  • Meritorious Winner in The Mathematical Contest in Modeling 2009
Languages

Fluent in English, Mandarin

Skills
  • SAS
  • R
  • SPSS
  • C++
  • MATLAB
  • WINBUG
  • MS OFFICE

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Resume Overview

School Attended
  • East China Normal University
  • University of Missouri
Job Titles Held:
  • Statistician
  • Associate Statistician, Biostatistics
  • Consultant
  • Team Leader
Degrees
  • B.A
  • M.A

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