Experience

RAM Software Solutions Inc

• IT Services and IT Consulting
• 1 - 100 Employee

• Principal Statistical Programmer Analyst

  • Jun 2013 - Present

  Provides statistical programming support for the analysis and reporting of clinical trial data for Client FSP project for Alexion Inc. • Program the tables, figures and data listings for interim and administrative analyses, and for the final statistical analyses that will be included in the Clinical Trial Report. Provide necessary programming to support scientific manuscripts and meeting presentations for clinical trial data. • Work with study biostatisticians to develop analysis plans for the Integrated Summary of Safety and the Integrated Summary of Efficacy required for NDA submissions. Program and validate the tables, figures and listings for the ISS and ISE according to ICH Guidelines, and the tables, listing an figures used for the Clinical Pharmacology and Biopharmaceutical Summaries. Create all analysis datasets for the production of the tables, listings and figures for the ISS and ISE, by combining CRF data from all clinical trials that will be part of the NDA submission. • Ensure that Adverse Event and Concomitant Medication coding, and any other database coding that has been used, has been consistently applied to the data for all patients in each clinical. • Creating SDTM/ADaM datasets using CDISC Standards and mapping. • Participate in establishing standardized templates for Biostatistics and Data Management, such as Statistical Reports, Safety Database Monitoring Reports, Clinical Trial Reports and Data Validation and Monitoring Plans. Show less



Santarus, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Statistical Programmer II

  • Oct 2012 - May 2013

  Provide statistical programming support for the analysis and reporting of clinical trial data at Santarus. DUTIES & RESPONSIBILITIES: Essential duties and responsibilities include the following. Other duties may be assigned. 1. Develop, validate and execute programs using SAS for the analysis and reporting of data from clinical trials; program the tables, figures and data listings for interim and exploratory analyses. Provide necessary programming to support scientific manuscripts and meeting presentations. 2. Periodically review and update standards for writing and validating programs according to ICH guidelines. 3. Create sponsor-defined and CDISC (SDTM and ADaM) datasets for statistical programming. 4. Collaborate with study biostatisticians to develop analysis plans for interim, administrative and final statistical analyses and analysis plans for the Integrated Summaries of Safety and Efficacy required for NDA submissions. 5. Participate in program validation activities. 6. Work with biostatisticians and other statistical programmers to create and maintain the SAS programming environment for Biostatistics and Data Management, including SAS macros, SAS includes, SAS format libraries and study-specific dataset libraries. 7. Work with Data Management to conduct QC checks of the database for each study. Participate in the reconciliation of any discrepancies that are found. 8. Provide support to Data Management to conduct QC procedures of the clinical trial database prior to database lock. 9. Participate in establishing standardized templates for Biostatistics and Data Management, such as Safety Database Monitoring Reports and Data Validation and Monitoring Plans. 10. Participate in writing Biostatistics and Data Management SOPs and guidelines. 11. Other duties as assigned. Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. Show less



XOMA

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Statistical Programmer Analyst

  • Nov 2011 - Oct 2012

  Provide statistical programming expertise and hands on support to clinical projects across multiple therapeutics areas.Lead statistical programming activities for clinical studies and participate in clinical study team meetings. Provide strong technical programming support to Biometrics and Data management. Contribute to activities in statistical systems development, validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools. Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices. Show less



Nektar Therapeutics

• Biotechnology
• 300 - 400 Employee

• Senior Statistical Programmer Analyst

  • Oct 2010 - Oct 2011

  Position Summary Provide statistical programming expertise and hands on support to clinical projects across multiple therapeutics areas.Lead statistical programming activities for clinical studies and participate in clinical study team meetings. Provide strong technical programming support to Biometrics and Data management. Contribute to activities in statistical systems development, validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools. Contribute in development and implementation of programming standards and conventions. Perform vendor qualifications in regards to statistical programming function and oversees and validate vendor's programming activities such as CDISC implementation, analysis files specifications, and analysis, and programming conventions. Develop SAS coding and table templates for preparing, processing and analyzing clinical data. Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices. Manage CRO regarding programming issues and activities to ensure timely delivery of tables and data listings. Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables.Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Show less



Hoffman La Roche

• Senior SAS Programmer/Analyst

  • Feb 2009 - Feb 2010

  • Wrote SAS programs/macros to produce TLG’s, analysis datasets and perform quality assurance for Phase II-IV Neurology trials for Schizophrenia and Alzheimer’s diseases in Central Nervous System. • Wrote functional specifications to provide programming guidelines to the study team prior to analysis start-up. • Mentored study programmers to ensure smooth on-boarding. Conducted phone interviews for short listing new consultants. • Organized team review meetings for deliverables. Kept a track of agreed changes and provided oversight to ensure that the changes are in effect. • Maintained documentation of team reviews and quality assurance. • Responsible for communication with data management team, statisticians and external vendors. Integrated outsourced trials in CDISC format to perform ISS/ISE reporting. Show less



Impax Laboratories

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Sr. Statistical Programmer Analyst

  • 2010 - 2010

  • Wrote SAS programs/macros to produce TLG’s, analysis datasets and perform quality assurance for Phase III Neurology trials for Parkinson’s disease in Central Nervous System. Preparing for NDA Submission in 2011. • Wrote functional specifications to provide programming guidelines to the study team prior to analysis start-up. • Responsible for creating CFR Part 11 compliant directory hierarchy at project initiation and setting up/ongoing changes of central macro library and study specific formats. Wrote generic SAS macros to aid the programming team in decreasing code redundancy. • Mentored study programmers to ensure smooth on-boarding. Conducted phone interviews for short listing new consultants. • Designed, specified and coded programs to build SDTM and ADAM datasets. Show less



smithhanley consulting group

• Sr. Statistical Programmer Analyst

  • 2003 - 2010



Viropharma Inc

• Sr. Statistical programmer Analyst

  • 2009 - 2009



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Applications Specialist-C

  • 2007 - 2009

  • Wrote SAS programs and macros for the analysis of data from Phase II - III immunology trials on Psoriasis, Crohn’s disease, Multiple Sclerosis, Rheumatoid Arthritis therapeutic areas. • Supported safety reporting team in creation of TLG’s, analysis datasets, analysis ready datasets and tables and ad-hoc requests in response to queries from FDA, PMDA, Health-Canada and EMEA. • Participated in team review meetings. Managed and tracked changes discussed in the meeting. • Performed quality assurance and maintained documentation. • Assisted in developing new tools and techniques for process efficiency and improvements. • Presented seminars to programming team to optimize internal systems and maintain a leading edge industry position. • Authored reports using eDocs for Electronic Submission of Clinical Study Reports and NDA Submissions to Food and Drug Administration. Show less



Targacept, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Statistical Programmer/Analyst

  • 2003 - 2007

  • Wrote SAS programs and macros for the analysis of Phase I and II clinical studies on ADHD, Major Depressive Disorder, Mild Cognitive Impairment (MCI), Age Associated Memory Impairment (AAMI) therapeutic areas in Neurology. • Performed Data analysis, statistical analysis, generated safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. • Assisted data management group to implement edit specifications for database quality control. • Reviewed Statistical Analysis Plans and provided Statistician with feedback from a programming perspective. Wrote programming specifications section in SAP. • Performed SAS code reviews to junior programmers. • In-charge of study set-up for programming team and maintain central macro/programming library and study-specific formats on an on-going basis. • Mentored associate SAS programmers and conduct telephone interviews to shortlist new consultants. • Created programs to manage resource allocation and improve process efficiency. • In charge of maintaining clean data from various sources, as required for analysis programming. • Functioned as project leader for ensuring completeness of assigned tasks having strict deadlines and budgetary guidelines. • Maintained technical knowledge in applications development expertise through research, technical bulletins, training, and attending appropriate. Show less



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Decision Support Analyst

  • 1999 - 2001

  • Worked as Lead Reporting Analyst for HGFU. • Created and maintained a Medical Request Tracking System (MEDREQ) for the study. • Identified new Macro requirements and changes for implementation. • Prepared for and attended planning meetings: Setup requirements according to the protocol and get proper approvals. • Monitored, updated, and finalized user requirements • Prepared for and attended Lock planning meeting- Study Lead is responsible for determining the timelines for a study report and coordinating with all team members. • Created and updated the Project Tracking System including resource requirements. • Updated information in Knowledge Database using Lotus Notes. • Setup an existing reporting system to handle a new study such as Maintenance Dose Macro requirements and development, Reference Tables, Therapy Table, Pooling, Phase Tables and Cross-Over Setup. • Designed, developed and generated user reports. Performed validation and integrity checks. • Archived documents such as peer reviews, requirement documents, test plans, and so on including the proper use of tools such as JCL’s, Macros or SAS Programs. Show less



ICRISAT-Patancheru

• Sr. Scientific Officer

  • 1983 - 1998

  • Worked on the development of resistance screening techniques and disease resistance screening of chickpea diseases • Designed experiments, collected data and set up a floor plan. • Analyzed user information and existing systems to establish the boundaries for computerization • Collected data, and conducted data entry using MS-Excel and analyzed of data using SAS/FSP, SAS/Base, SAS/STAT and SAS/Graph. • Evaluated alternatives for satisfying user requirements. • Prepared program specifications, program libraries and test plans. • Developed disease resistance screening techniques. • Planed and organized data collection, computerization of databases, data processing, data validation, statistical analyses, report writing, preparation of graphs, and collaboration with NARs. • Maintained programs for incorporated changes. • Developed SAS/Macros for retrieval and selection of resistance sources by accessing SAS/SQL • Created macros for data analysis and report generation. • Publication and report writing Show less