Data Clinical

Elodie Samson, M.Sc

*** ******** ******, *** ***, San Francisco, CA, 94105, USA

Tel: 415-***-****

Email: ************@*****.***

OBJECTIVE

A position in which my statistical expertise and my programming aptitudes will allow me to actively contribute to a multidisciplinary challenging and dynamic work environment.

SUMMARY

-7 years of experience as a Biostatistician in the pharmaceutical industry and medical research in several therapeutic areas

-Comprehensive knowledge of clinical trials methodology

-Strong skills in a wide range of statistical analyses

-Strong programming skills and understanding of database structures in a clinical data environment

-Knowledge of ICH and CDISC data standards including SDTM and ADaM

-Strong verbal/written communication, presentation and documentation skills

-Self-motivated, with ability to work independently with minimal supervision or collaboratively with a team

-Ability to support multiple assignments with challenging timelines

SPECIFIC SKILLS

Statistics

Survival analysis

Parametric and Nonparametric statistical procedures: t-Test, Wilcoxon Test, Kruskal-Wallis Test, Chi-Square Test, Fisher’s Exact Test, McNemar’s Test, Cochran-Mantel-Haenszel Test, …

Power, sample size calculation

Linear regression, Analysis of Covariance, Logistic regression, Hierarchical Ordered Probit model, Analysis of variance, Mediation analysis, Mixed models, GEE, Anchoring Vignettes, Factor analysis, Bootstrapping

Genetic association studies

Clinical studies

Clinical trials, Crossover clinical trials, Observational studies, Genome-wide association studies, Biomarker studies, Cross-sectional and Longitudinal studies, Pre-clinical studies

Computer knowledge

Statistical software : SAS 9.2: SAS/BASE-STAT-GRAPH-REPORT-SQL-MACRO-GENETICS, R, PASS, Mplus, STATA, SPSS

Office automation software : WORD, EXCEL, POWERPOINT

Operating Systems: WINDOWS, UNIX

Therapeutic Areas: Oncology, Ophthalmology, Liver Diseases, Psychiatry, Pediatrics, Neurology, Respiratory Diseases, Dermatology

Language skills: French, English

WORK EXPERIENCE

Consulting Biostatistician August 2011 to present

Ophthalmology Research Center, Hôpital Maisonneuve-Rosemont

Work as a Biostatistician on clinical trials, observational and pre-clinical studies (Ophthalmology)

Responsible for statistical aspects of assigned projects, including sample size estimation, statistical analyses, and presentation of data. Develop statistical analysis plans

Assist researchers in the design of study databases

Create analysis datasets, perform statistical analysis and interpret results of analyses

Write and review statistical reports and sections of data analysis for scientific papers, abstracts and research protocols

Respond to statistical questions raised by regulatory agencies and institutional review boards

Senior Statistical Programmer December 2013 to present

Gilead Sciences, Inc. Foster City

Work as the lead statistical programmer on multiple Phase I-III clinical trials (Oncology and HCV)

Work collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting

Act as a liaison between Biostatisticians, Programmers and Clinical Data Managers working on study for addressing complex data, programming and data issues

Manage a team of 4-5 programmers. Assign tasks to statistical programmers. Coordinate activities with other functional groups to ensure timeliness and quality of project deliverables

Discuss time estimates for completion of study related activities with Biostatistics management and proactively communicate any difficulties with meeting these timelines

Assist in the development/review of key study-related documents, e.g. Statistical Analysis Plan (SAP), Case Report Form, Data Management Plan, database specifications, Data Cut plan and other clinical documents

Responsible for the development, validation, execution, maintenance, documentation, and archival of analysis datasets and programming code used in the analysis of clinical trial data

Write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets

Write, test and validate SAS programs to perform statistical analyses, produce datasets, tables, listings, figures and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications

Conduct and participate in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in SAP

Develop statistical reports, patient profiles, and ad-hoc reports based on specifications in analysis plan

Assist in the preparation of submissions of electronic data to regulatory agencies

Provide support to, train and mentor junior and advanced programmers

Develop project specific and departmental standardized programming tools and routines for analysis

Provide input to and participate in intra-departmental meetings

Environment [Unix, Windows, Excel, Word, SAS 9.2)

Biostatistician June 2012 to December 2013

Everest Clinical Research Services Inc. Greater Toronto Area

Work as a Biostatistician on multiple Phase I-IV clinical trials (Oncology, Psychiatry, Pediatrics, Respiratory Diseases and Dermatology)

Work collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting

Participate in project meetings

Assist in the review of key study-related documents produced by other functions, e.g. Protocol, Case Report Form, Data Management Plan, database specifications and other clinical documents

Oversee statistical aspects of assigned projects and provide support in study design, statistical analysis, and reporting of data

Coordinate activities with other functional groups to ensure timeliness and quality of project deliverables

Write and review Statistical Analysis Plans based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures

Responsible for the accuracy and completeness of statistical analyses conducted for assigned projects

Responsible for the development, validation, execution, maintenance, documentation, and archival of analysis datasets and programming code used in the analysis of clinical trial data

Write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets

Write, test and validate SAS programs to produce datasets, tables, listings, figures and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications

Conduct and participate in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in SAP

Participate in the development and maintenance of, and adhere to corporate policies and SOPs

Environment [Unix, Windows, Excel, Word, SAS 9.2)

Biostatistician October 2011 to June 2012

Biostatistical Consulting Service,

Center for Addiction and Mental Health (CAMH) Toronto

Work as the lead Biostatistician on multiple clinical trials and observational studies (Neurology, Psychiatry and Pediatrics)

Provide statistical consultation on trial design and study endpoints. Responsible for statistical aspects of assigned projects, including experimental design, sample size estimation, patient randomization, statistical analyses, and presentation of data. Develop statistical analysis plans

Assist researchers in the design of study databases

Create analysis datasets, perform statistical analysis and interpret results of analyses

Responsible for the accuracy and completeness of statistical analyses conducted for assigned projects

Collaborate on grant applications with scientists

Write and review statistical reports and sections of data analysis for scientific papers, abstracts and research protocols

Environment [Windows, Excel, Word, SAS 9.2, R, Mplus, AMOS, SPSS)

Biostatistician August 2010 - October 2011

Ophthalmology Research Center, Hôpital Maisonneuve-Rosemont Montreal

Work as the lead Biostatistician on multiple clinical trials, observational and pre-clinical studies (Ophthalmology)

Responsible for statistical aspects of assigned projects, including experimental design, sample size estimation, statistical analyses, and presentation of data. Develop statistical analysis plans

Assist researchers in the design of study databases

Create analysis datasets, perform statistical analysis and interpret results of analyses

Participate in the reporting of study results, in regulatory submissions to Health Canada and other regulatory agencies

Manage large datasets (World Health Organization databases and World Bank databases), create maps in SAS

Use Anchoring Vignettes to Examine Cross-Regional Differences in Self-Reported Difficulty with Near Vision. Explain the anchoring vignette methodology to statisticians, epidemiologists and other researchers

Collaborate on grant applications with scientists

Write and review statistical reports and sections of data analysis for scientific papers, abstracts and research protocols

Respond to statistical questions raised by regulatory agencies and institutional review boards

Supervise the students and colleagues who don’t have a strong background in statistics

Present the statistical methods at conferences

Environment [Windows, Excel, Word, SAS 9.2, R, STATA, SPSS)

Biostatistician September 2008 – August 2010

Cancer Research Center, CHUQ, HDQ Quebec

Work as the lead Biostatistician on multiple clinical trials, genome-wide association studies, biomarker and observational studies (Oncology)

Responsible for statistical aspects of assigned projects, including sample size estimation, statistical analyses, and presentation of data. Develop statistical analysis plans

Assist researchers in the design of study databases

Create analysis datasets, perform statistical analysis and interpret results of analyses

Manage large datasets, write SAS macros to analyze more than 500 000 single nucleotide polymorphisms and create regional association plots

Participate in the reporting of study results, in regulatory submissions to National Cancer Institute of Canada, Health Canada and other regulatory agencies

Collaborate on grant applications with scientists

Write and review statistical reports and sections of data analysis for scientific papers, abstracts and research protocols

Respond to statistical questions raised by regulatory agencies and institutional review boards

Attend monthly research meetings to discuss scientific articles and statistical methods

Supervise the students and colleagues who don’t have a strong background in statistics

Present the statistical methods at conferences

Environment [Windows, Excel, Word, SAS 9.1.3, SAS 9.2, R, PASS)

Teaching Assistant 2007 - 2008

Laval University Quebec

Offer tutorial sessions for courses in statistical methods, engineering statistics and probabilities, statistics and mathematics for engineers

Help undergraduate students understand statistical and mathematical concepts

Assist students with their assignment and with time management skills

Solve the exercises on the black board, explain the statistical concepts to the students (2 hours per week) and mark the exams

EDUCATION

Master’s degree in Biostatistics 2008 Laval University Canada

Dissertation:

Advisor: Thierry Duchesne

Title: Stratified Cox Proportional Hazards Models to Identify Serum Prognostic Markers in Head and Neck Cancer

Master’s degree (Maitrise) in Statistics and Mathematics 2006

University College Cork Ireland

Bachelor’s degree in Mathematics and Computer sciences 2005 Rennes University France

SELECTION OF PUBLICATIONS AND PRESENTATIONS

Ellen E Freeman, Marie-Hélène Roy-Gagnon, Elodie Samson, Slim Haddad, Marie-Josée Aubin, Claudia Vela, Maria Victoria Zunzunegui. The global burden of visual difficulty in low, middle, and high income countries. PLoS One 2013 10;8(5):e63315. Epub 2013 May 10

Claudia Vela, Elodie Samson, Maria Victoria Zunzunegui, Slim Haddad, Marie-Josée Aubin, Ellen E Freeman. Eye care utilization by older adults in low, middle, and high income countries. BMC Ophthalmol 2012 3;12. Epub 2012 Apr 3

Azad AK, Bairati I, Samson E, Cheng D, Mirshams M, Qiu X, Savas S, Waldron J, Wang C, Goldstein D, Xu W, Meyer F, Liu G. Validation of genetic sequence variants as prognostic factors in early-stage head and neck squamous cell cancer survival. Clin Cancer Res. 2012 Jan 1;18(1):196-206. Epub 2011 Nov 10.

Abul Kalam A, Bairati I, Samson E, Cheng D, Cheng L, Mirshams M, Savas S, Waldron J, Wang C, Goldstein D, Xu W, Meyer F, Liu G. Genetic Sequence Variants and the Development of Secondary Primary Cancers in Patients with Head and Neck Cancers. Cancer. 2012 Mar 15;118(6):1554-65. doi: 10.1002/cncr.26446. Epub 2011 Aug 25.

Samson E, Zunzunegui MV, Haddad S, Aubin MJ, Freeman E. The Use of Anchoring Vignettes to Examine Cross-Regional Differences in Self-Reported Difficulty with Near Vision. Presentation at 23rd ophthalmology departmental Research Day, Montreal, Canada, June 2011

Oliver K, Jaworski L, Samson E, Freeman E, Bélair ML, Aubin MJ, Fortin E. Visual Impairment, Visual Function And Quality Of Life Among Uveitis Patients In A North American Population. ARVO 2011, Fort Lauderdale, Florida, USA, May 1-5 2011

Meyer F, Samson E, Douville P, Duchesne T, Liu G, Bairati I. Serum prognostic markers in head and neck cancer. Clinical cancer research: an official journal of the American Association for Cancer Research, 2010. 16: 1008-15

Meyer F, Liu G, Douville P, Samson E, Xu W, Adjei A, Bairati I. Dietary vitamin D intake and serum 25-hydroxyvitamin D level in relation to disease outcomes in head and neck cancer patients. International journal of cancer, 2010. Epub

Nourissat A, Bairati I, Samson E, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Meyer F. Predictors of weight loss during radiotherapy in patients with stage I or II head and neck cancer. Cancer, 2010. Epub

Samson E, Xu W, Bairati I, Meyer F, Abul Kalam A, Liu G. Stratified Cox Proportional Hazards Models to Identify Genetic Prognostic Markers in Head and Neck Cancer Based on Different Genetic Models. 38th Annual Meeting of the Statistical Society of Canada, Quebec, Canada, May 23-26, 2010

Meyer F, Samson E, Bairati I. Health-related quality of life as an outcome predictor for patients with localized head and neck carcinoma treated with radiation therapy. MASCC/ISOO International Symposium, Rome, Italia, June 2009

Samson E, Meyer F, Duchesne T, Douville P, Bairati I. Stratified Cox Proportional Hazards Models to Identify Serum Prognostic Markers in Head and Neck Cancer. Journée scientifique des étudiants 2008, August 2008, Quebec, Canada

AWARDS

Honor roll from the faculty of graduate studies for the year 2008 2008

Laval University Quebec

Merit-based scholarship from the Canadian Research Chair in Sampling 2007-2008

and Data Analysis

Laval University Quebec

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