Anita S.

Highly experienced biostatistician with excellent team building skills and proficient in variety statistical data analysis for several therapeutic areas seeking a senior statistician position in Pharmaceutical/contract research organizations. Education Masters in Public Health (MPH) (Biostatistics), University of North Texas, US (GPA 3.8) 2006 Doctor of Medicine (MD- Internal Medicine), Maharashtra Univ. of Health Sciences (MUHS), India 2004 Awards/Certifications and Skills Certification in base SAS9 programming CCIM India licensed medical practitioner Weapons of Mass Destruction (WMD) Radiological-Nuclear awareness certification FEMA IS-00700 certification for National Incident Management System Proficiency in MS-Excel, R, PASS, SPSS and S-Plus Executive Summary 6 ½ years of experience in statistical analysis for clinical trials Develop SAP and table, listing figure (TLF) shells Devise statistical section of the protocol Sample size calculation using SAS, PASS, SS estimation for adaptive group sequential design using EAST software Generate randomization schedules lists and in detail specification document for randomization implementation plan Review data validation specification (DVS) document to ensure accuracy and completeness of edit checks Review case report forms (CRFs) to ensure their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis Provide QC statistical programming support for checking TLFs Lead project team meetings and collaborate resources, external project information, and timelines to achieve in time submission of the deliverable Attend meetings with investigators, medical personnel and data management Data analysis: using Analysis of variance, linear and non-linear mixed effect models, Bayesian analysis, categorical data analysis, univariate and multivariate analysis and nonparametric techniques, survival analysis, Poisson regression modeling, Negative binomial regression modeling and rate ratio calculation Perform ISS and ISE analysis Knowledge of adaptive design concepts and methodology Knowledge of regulatory guidelines relating to statistical analysis Extensively acquainted with and used the E9 Statistical Principles for Clinical Trials Develop SAP and table, listing figure (TLF) shells Devise statistical section of the protocol Sample size calculation using SAS, PASS Generate randomization schedules lists and in detail specification document for randomization implementation plan Review data validation specification (DVS) document to ensure accuracy and completeness of edit checks Review case report forms (CRFs) to ensure their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis Provide QC statistical programming support for checking TLFs Lead project team meetings and collaborate resources, external project information, and timelines to achieve in time submission of the deliverable Attend meetings with investigators, medical personnel and data management Data analysis: using Analysis of variance, linear and non-linear mixed effect models, Bayesian analysis, categorical data analysis, univariate and multivariate analysis and nonparametric techniques, survival analysis, Poisson regression modeling, Negative binomial regression modeling and rate ratio calculation Perform ISS and ISE analysis Knowledge of regulatory guidelines relating to statistical analysis Extensively acquainted with and used the E9 Statistical Principles for Clinical Trials