SUMMARY:

• Clinical Research Professional with over 12 years of clinical trial experience and Master degrees in Statistics and Mathematics.
• Experience in providing SAS programming, Biostatistics and Data Management support for phase I - III trials.
• Good communication skills. Therapeutic areas include oncology, hematology, cardiology, infectious diseases and diabetes.
• Good understanding of GCP and ICH guidelines. Sound understanding of clinical trials practices, procedures, methodologies .

AREAS OF EXPERTISE:

• BASE
• STAT
• MACRO
• ODS
• SQL and GRAPH.

PROFESSIONAL EXPERIENCE:

Confidential, Princeton, NJ

Principal Statistical Programmer

• Oversaw technical planning for projects including Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) and electronic submissions
• Authored Analysis Data Reviewers Guide for Integrated Summary of Efficacy submissions
• Reviewed and interpreted Statistical Analysis Plans and provided comments for assigned projects
• Ensured quality of personal work while meeting completion dates with minimal supervision
• Provided ongoing supervision, advice and consultation to Lead Programmers and programming team to ensure timely and efficient completion of projects
• Carried out all activities according to Confidential SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).
• Created and validated SDTM and ADAM datasets
• Created and validated tables, listings and graphs for ongoing studies

Confidential, Newton, MA

Senior Statistical Programmer

• Implemented Statistical Analysis Plans
• Supervised statistical programming activities performed by a CRO.
• Generated tables, listings and figures for regulatory submissions including DSURs and IBs
• Generated tables, listings and figures for Interim Analyses
• Coordinated in-house statistical programming activities ensuring timelines are met and best practices implemented
• Communicated process improvement ideas within the department
• Reviewed Case Report Forms and Statistical Analysis Plans for phase II and III studies
• Performed sample size calculations using SAS and PASS
• Created and reviewed Programing SOPs

Confidential, Waltham, Massachusetts

Senior QCP Programmer

• Created input data files using SAS for NONMEM software which is used to conduct a population PK or population PKPD analysis in phase I and II trials
• Provided strategic input and leadership to the delivery of all technical programming and information components of a QCP deliverables.
• Contributed to the development of best practice to improve quality, efficiency and effectiveness

Confidential, Canton, Massachusetts

Principal SAS Programmer

• Created ADAM and SDTM datasets
• Produced safety tables and listings
• Performed quality checks on SDTM and ADAM datasets
• Validated safety tables and listings
• Created custom SAS exports

Confidential, Cambridge, Massachusetts

Senior Statistical Programmer

• Ensured consistency of datasets from different vendors
• Created analytical datasets from CDISC-compliant data
• Produced tables listings and graphs for completed and ongoing I-III studies
• Produced tables and listings for SCS and SCE
• Performed quality checks on tables listings and graphs for phase I-III studies
• Complied with study standards by following internal guidelines
• Performed analyses of Quality of Life Data
• Conducted analyses of primary and secondary cancer endpoints
• Provided programming support for ad-hoc tables listings and graphs
• Reviewed data transfer specifications
• Performed quality checks on datasets received from vendors using specifications provided
• Participated in preparation for ODAC meetings
• Contributed to periodic DSURs
• Supported rapid responses to FDA

Confidential, Boston, Massachusetts

Teaching Assistant

• Addressed students’ questions regarding class material and homework via e-mail or in person
• Graded Students’ Homework

Confidential, Cambridge, Massachusetts

SAS, Biostatistics, Data Management and Regulatory consultant

• Re-programmed already-existing Tables and Listing for Phase II and III clinical trials
• Created and updated tables and listings for Investigator Brochure
• Revised Statistical Analysis Plans for Phase II studies in preparation for database lock
• Participated in close-out activities for the completed studies
• Revised Date Management Plans for Phase II studies
• Participated in close-out activities for the completed studies
• Trained newly hired personnel
• Performed literature searches in the area of Hematology
• Assisted with EU regulatory submissions
• Translated documents and guidelines from Russian into English and English into Russian

Confidential, Boston, Massachusetts

Clinical Data Manager

• Reviewed Statistical Analysis Plans for phase I-III studies
• Resolved statistical issues in individual clinical studies
• Created ad-hoc tables and listings for pre-clinical and clinical studies
• Perform quality checks on existing Tables, Listings and Figures.
• Reviewed and updated Investigational Brochure
• Calculated sample sizes for various types of studies
• Reviewed randomization schedules
• Performed SQL queries using SAS
• Created reports for a Phase III trial using Inform Clinical Trial Management System
• Created data management and Data Transfer Plans for Phase I and III studies
• Reviewed data validation specifications
• Reviewed IVRS specifications
• Created Case Report Forms
• Participated in creation of drug supply algorithms
• Developed Standard Operating Procedures in the areas of Data Management and Programming
• Communicated status of ongoing Data Management and Programming projects to senior management
• Further enhanced the knowledge of applicable FDA, ICH and EMEA guidelines
• Reviewed study protocols for Phase I and III studies in Infectious Diseases
• Conducted literature searches in areas relevant to infectious diseases as well as statistical clinical and data management methodology for ongoing studies

Confidential, Cambridge, Massachusetts

Clinical Programmer

• Created and reviewed Standard Operating Procedures
• Created SAS code for tables and listings for phase II and III trials
• Used SAS Macro facility for task automation
• Coordinated SAS upgrades and licenses
• Developed and implemented programming conventions
• Performed literature searches to identify and implement appropriate techniques and methodologies
• Became familiar with SDTM and ADAM standards
• Designed and implemented edit checks
• Facilitated data cleaning in SAS
• Annotated Case Report Forms
• Supervised programming activities of a Contract Research Organization programmers
• Provided guidance to new department members
• Became knowledgeable in FDA, ICH and EMEA guidelines
• Provided assistance with regulatory submissions
• Created and maintained Standard Operating Procedures
• Provided technical oversight in the areas of analysis and reporting
• Reviewed clinical protocols, investigator brochures, manuscripts and presentations
• Developed strong interpersonal, verbal, written and multitasking skills
• Acquired knowledge in areas of hematology, trauma and cardiology

Statistical Consultant

• Participated in the creation of and performed analyses according to Statistical Analysis Plans
• Participated in creation of Investigator’s Brochure
• Performed ad-hoc and post-hoc statistical analyses for Phase II and III trials

Data Management Intern

• Manually reviewed Adverse Event database for several Phase III trials
• Provided input into creation of Case Report Form Completion Guidelines

Confidential, Salem, Massachusetts

College Mathematics Tutor

• Provided tutoring to undergraduate students in mathematics curricula.