statistician iii resume example with 12+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
:
single:
:
Professional Summary
Dedicated statistician skilled in providing statistical support for all phases of clinical trials. Over ten years of experience in managing statistical aspects of evidence generation strategies, clinical trial design, data analysis planning and implementation, and reporting. Demonstrated leadership in collaborating within cross-functional teams for simultaneous projects. Customer-focused, motivated and adaptable professional, with in-depth statistical knowledge.
Key Skills
Clinical trial design
Sample size calculation and protocol development
Extensive knowledge of statistical methods used in clinical trials
Regulatory guidance knowledge
Ability to communicate technical concepts to non-statisticians
Adaptable, with ability to effectively collaborative in cross-functional teams or work independently
Leadership and organizational skills while working on multiple projects
Experience
Statistician III, 02/2005 - 06/2015 Novavax – Gaithersburg, MD,
Lead various collaborative initiatives with Clinical Research, Medical Affairs and Health Economics teams in order to develop statistical support for evidence generating strategies, study reports, publications and white papers.
Perform sample size calculations and create randomization schedules.
Lead statistical insert in study protocols for IDE studies and post-launch regulated clinical trials with the implementation of HCC.
Provide scientifically sound statistical methodology appropriate to the study design for study protocols, including adaptive sequential design.
Partner with the study teams in the process of responding to the FDA and external regulatory agencies (CFDA, PMDA, EMEA) inquiries.
Generate statistical analysis plans based on approved study protocols and ensure implementation by generating summary tables, data listings and statistical analysis output.
Analyze and interpret data from safety, efficacy and effectiveness clinical trials.
Use SAS for modeling procedures, to produce customized output and ensure output format consistency by developing and using SAS macros.
Develop statistical reports ultimately used to make key project decisions.
Provide statistical support for reporting activities in agreement with approved Statistical Analysis Plan and regulatory guidance, and for generation of manuscripts for publications and white papers for marketing.
Provide statistical support for wound management, women's health, urology and other surgery product studies.
Biostatistician, 03/2003 - 02/2004 Iqvia Holdings Inc – Valencia, CA,
Provided randomization schedules and developed reporting and analysis plans.
Analyzed clinical data using SAS procedures LOGISTIC, GENMOD, GLM, NPAR1WAY, REG.
Performed repeated measures analyses with SAS MIXED procedure, analysis of variance, categorical data analysis and regression techniques.
Provided statistical reports for bioavailability, drug interaction, modified release formulation, food effect, dose proportionality studies in Cardiovascular, Oncology, Epidemiology therapeutic areas.
Collaborated with clinical research scientists and other team members for different compounds in order to provide the final documents (protocols, reporting and analysis plans, study reports).
QC'ed statistical inserts, SAS and S-plus programs, statistical reports.
Statistical Consultant, 07/2002 - 02/2003 Purdue University – Goshen, IN,
Met clients from different fields and prepared written recommendations for their projects.
Used variable selection for multiple regression, polynomial and logistic regression, regression diagnostics, categorical predictor regression, cluster analysis and multivariate analysis of variance.
Used software packages such as SAS, Minitab, SPSS, S-plus, and Matlab.
Graduate Teaching Assistant, 07/2001 - 02/2003 Department Of Statistics, Penn State University – City, STATE,
Assisted students on their homework and computer projects, graded homework, exams and projects
Organized TA meetings, scheduled exams, developed grading schedules.
Education
M.S.: Statistics, Expected in 2003 - University of Pennsylvania - University Park, PA GPA: Status -
Cumulative GPA: 3.74
M.S.: Quantitative Economics (Econometrics), Expected in 2001 - University of Oradea - Oradea, GPA: Status -
B.S.: Economics, Expected in 1999 - University of Timisoara - Timisoara, GPA: Status -
Strong quantitative/analytical skills and organizational aptitudes
Languages: native Romanian; fluent English; fluent Spanish; read, write French
Awards
Johnson and Johnson Standard of Leadership Award for significant contribution to evidence generation for FDA approval of SURGIFOAM Gelatin Sponge with human thrombin for general hemostasis indication
Interests
Professional areas of interest: Biostatistics, Statistical Consulting
American Statistical Association member since November 2001
Community Involvement: Ballroom Dance Society, University of Pennsylvania
President, "Constructorul" Ballroom Dance Society, Oradea, Romania 6/1999-8/2001
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