Sofia Fleyshman's Email Addresses & Phone Numbers

Principal Statistician @ Cytel Associate Director @ Insmed Incorporated Leading statistical activities related to clinical trials from protocol to CSR development. Managing statistical vendors, leading and managing internal quality control of the deliverables, engaging in cross functional team decisions. Working in Pulmonary therapeutic area.Important duties include:• Working as a leading statistician in a cross functional team to...

Principal Statistician @ Cytel Associate Director @ Insmed Incorporated Leading statistical activities related to clinical trials from protocol to CSR development. Managing statistical vendors, leading and managing internal quality control of the deliverables, engaging in cross functional team decisions. Working in Pulmonary therapeutic area.Important duties include:• Working as a leading statistician in a cross functional team to design and/or review protocols, including sample size estimation and statistical methods), case report forms, statistical analysis plans, randomization, analysis file specifications, and other clinical trial related documents• Analyzing clinical trial data, managing internal and external teams to produce accurate results representing the outcome of the trial, validating statistical output• Performing complex statistical analyses, accurately interpreting and clearly communicating statistical results and concepts to non-statisticians, and assisting in preparation of study reports including summaries for FDA submissions.• Supporting exploratory analyses, AdHoc, and other requests from internal functionsSoftware Utilized: SAS, WinNonLin, Nquery, MS Office From July 2018 to August 2019 (1 year 2 months) Bridgewater,NJBiostatistician II @ Acorda Therapeutics, Inc. Responsible for developing, modifying and evaluating statistical elements of clinical trials and basic research, under minimal supervision, evaluation of databases and statistical analyses programs. • Working as a member of a team to design and/or review protocols, case report forms, and statistical analysis plans. • Reviewing protocols and case report forms for soundness of trial design.• Developing statistical analysis plans including analysis files and report specifications.• Supporting creation of publication material from a statistical perspective.• Performing advanced statistical analyses, interpreting statistical results and helping prepare study reports including summaries for FDA submissions.• Assisting with clinical study design and protocol amendments.• Performing relevant sample size calculations.• Authoring or reviewing statistical sections of clinical study reports. • Assisting with the development and/or improvement of standard operating procedures, work instructions, standard statistical computer programs.• Writing advanced statistical plans, protocols and reports. From April 2014 to April 2017 (3 years 1 month) Ardsley, NYBiostatistician I @ Acorda Therapeutics, Inc. Responsible for developing, modifying and evaluating statistical elements of clinical trials and basic research, under close supervision, evaluation of databases and statistical analyses programs. • Working as a member of a team to design and/or review protocols, case report forms, and statistical analysis plans. • Reviewing protocols and case report forms for soundness of trial design.• Developing statistical analysis plans including analysis files and report specifications.• Supporting creation of publication material from a statistical perspective.• Performing basic statistical analyses, interpreting statistical results and helping prepare study reports including summaries for FDA submissions.• Assisting with clinical study design and protocol amendments.• Performing relevant sample size calculations.• Authoring or reviewing statistical sections of clinical study reports. • Assisting with the development and/or improvement of standard operating procedures, work instructions, standard statistical computer programs.• Writing basic statistical plans, protocols and reports. From June 2012 to April 2014 (1 year 11 months) Ardsley, NYBiostatistician @ Siemens Healthcare Diagnostics Providing autonomous on-site real-time statistical support of the manufacturing facility and working with other statisticians. Responsible for performing statistical analysis in SAS to implement advanced data manipulation and customer understandable visual output and in Excel to generate user-friendly tool for customer usage. Important duties included: • Providing experiment design for manufacturing processes and assay development. • Development of user friendly excel spreadsheet tools • Generating specifications based on the analysis of product quality data. • Writing SAS programs for statistical analyses of data from various sources (SAS datasets, database, excel spreadsheets, text documents, etc.) • Establish assay capabilities based on the precision profile, including new products with limited data • Providing quality review of SAS, HTML, and other codes generated by other statisticians, completing pre-validation and validation of user • Creating supporting documents for protocol changes, explaining the benefits of new methods in a way From June 2010 to January 2012 (1 year 8 months) Walpole, MAGrader, Regression Analysis (graduate level course) @ University of Massachusetts Amherst responsible for correcting, grading, and commenting on the students’ homeworks according to given guidelines. From September 2008 to December 2010 (2 years 4 months) Amherst, MATeaching Assistant, Elementary Statistics and Introduction to Statistics @ University of Massachusetts Amherst ▪ Was responsible for two sections of a large lecture course: prepared and taught discussion sections, held office hours for the students, providing one-on-one and group assistance.▪ Corrected collected homeworks, quizzes, and exams; From September 2008 to January 2010 (1 year 5 months) Amherst, MASecurity monitor @ University of Massachusetts Amherst ▪ Maintained the daily log of guests for the designated residence hall.▪ Was responsible for reporting unusual conditions and safety concerns.▪ Worked 30+ hours per week. From September 2006 to January 2008 (1 year 5 months) Amherst, MAStudent Instructor Leader, Multivariate Calculus @ University of Massachusetts Amherst responsible for holding out-of-class group help sessions, providing assistance with the homework, and clarifying the material covered in regular lectures. From February 2007 to May 2007 (4 months) Amherst, MAGrader, Honors Calculus II @ University of Massachusetts Amherst responsible for correcting, grading, and commenting on the student's homeworks according to given guidelines; keeping records of the grades. From September 2006 to December 2006 (4 months) Amherst, MAOffice Assistant @ University of Massachusetts Amherst ▪ Processed payments from event attendees.▪ Prepared printed materials for conferences and workshops.▪ Worked with various teams to help time-constrained projects. From February 2006 to May 2006 (4 months) Amherst, MAPrintShop Assistant @ Western New England College Was responsible for accurately and timely processing customers’ orders From September 2005 to December 2005 (4 months) Springfield, Massachusetts AreaOffice Assistant @ Fitzgerald and Associates PA ▪ Helped create the database of all the firm’s clients.▪ Helped with various office tasks (scanning, entering data, mailing, etc). From November 2004 to June 2005 (8 months) Charlottesville, Virginia AreaSenior Biostatistician @ Cytel Providing statistical input into Phase I - IV clinical trial development and NDA ready processes, performing the analysis of clinical trial data, AdHoc requests, statistical plans for study level and across study (like ISS) analyses, providing statistical input into the reporting of clinical trial results. Working directly as a member of statistical team within Shire in Immunology therapeutic area. Important duties included: • Communicating with clients regarding study protocol or statistical analysis issues • Analyzing clinical trial data producing accurate results representing the outcome of the trial, validating statistical output • Accurately interpreting and clearly communicating statistical results and concepts to non-statisticians • Providing statistical input into protocol and case report form (CRF) development in all aspects(e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data), writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures • Performing complex statistical analyses, interpreting statistical results and helping prepare study reports including summaries for FDA submissions. • Supporting AdHoc requests from all external and internal functions From May 2017 to July 2018 (1 year 3 months)