Experience

Resolutum Global Pty Ltd

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Principal Statistical Programmer

  • May 2022 - Present

  - Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities on the assigned portfolio of projects. - Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. - Coordinate and lead a statistical programming team to successful completion of projects within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. - Interact with sponsors and internal stakeholders about statistical programming issues. - Produce datasets, tables, listings, and figures (TLFs), or other outputs requested per programming specification, Statistical Analysis Plan (SAP) or other study related documentation, using SAS® Software (BASE, STAT, GRAPH, MACRO) on assigned projects. - Ensure the accuracy and consistency of data flow from case report forms (CRFs) to specifications for analysis datasets. - Perform quality control of datasets and TLFs developed by other programmers and biostatisticians. - Review project documentation such as SAP, mock shells, programming specifications and annotated CRFs. - Lead the creation, maintenance, and validation of programming tools, outputs, and macros. - Be aware of new developments in statistical programming that are relevant to the industry. Show less



Novotech

• Australia
• Biotechnology Research
• 700 & Above Employee

• • May 2021 - May 2022

  - Provide input into statistical analysis plans with respect to presentation of data and results (tables, listings, figures) and advise project staff with requirements in relation to data collection, storage and tabulation (CDASH, SDTM, ADaM)- Interprets specifications, technical designs and flow charts, builds, maintains and modifies the code for software applications, constructs technical specifications from a business functional model, and tests and writes technical documentation.- Develop and validate SAS programs for the tabulation of data, preparation of subject listings, graphical output and statistical analysis of data.- Develop and maintain a library of validated programs based on CDISC (CDASH, SDTM, ADAM), and regulatory guidance for data submissions, in particular FDA.- Act as Project Programmer for assigned projects involving multiple studies, and ensure consistency in - data structuring and presentation- Act as mentor to junior statistical programmers and conduct training activities Show less

• • Apr 2020 - May 2021

  - Provide input into statistical analysis plans with respect to presentation of data and results (tables, listings, figures) and advise project staff with requirements in relation to data collection, storage and tabulation (CDASH, SDTM, ADaM)- Interprets specifications, technical designs and flow charts, builds, maintains and modifies the code for software applications, constructs technical specifications from a business functional model, and tests and writes technical documentation.- Develop and validate SAS programs for the tabulation of data, preparation of subject listings, graphical output and statistical analysis of data.- Develop and maintain a library of validated programs based on CDISC (CDASH, SDTM, ADAM), and regulatory guidance for data submissions, in particular FDA.- Act as Project Programmer for assigned projects involving multiple studies, and ensure consistency in - data structuring and presentation- Act as mentor to junior statistical programmers and conduct training activities Show less



IQVIA

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

• • May 2019 - Apr 2020

  - Operational Team Lead.- Program, test, and document statistical programs for use in creating statistical tables, figures and listings.- Program, test, and document analysis datasets (derived datasets) and transfer files for internal and external clients.- Program quality control checks for the source data and report the data issues periodically- Assist in development of programming documentation including plans and specifications, as appropriate, under supervision.- Assist in developing, implementing and validating new process technologies, macros and applications, under supervision.- Assist project lead in fulfilling project responsibilities. Show less

• • Apr 2017 - Apr 2019

  - Operational Team Lead.- Program, test, and document statistical programs for use in creating statistical tables, figures and listings.- Program, test, and document analysis datasets (derived datasets) and transfer files for internal and external clients.- Program quality control checks for the source data and report the data issues periodically- Assist in development of programming documentation including plans and specifications, as appropriate, under supervision.- Assist in developing, implementing and validating new process technologies, macros and applications, under supervision.- Assist project lead in fulfilling project responsibilities. Show less

• • Jul 2015 - Mar 2017

  - Program, test, and document statistical programs for use in creating statistical tables, figures and listings.- Program, test, and document analysis datasets (derived datasets) and transfer files for internal and external clients.- Program quality control checks for the source data and report the data issues periodically- Assist in development of programming documentation including plans and specifications, as appropriate, under supervision.- Assist in developing, implementing and validating new process technologies, macros and applications, under supervision. Show less

• • Jul 2014 - Jul 2015

  - Supporting Argus Safety application- Oracle Database tasks - Working with Integrations for Argus Safety- Writing knowledge base articles and formal documentation- Provide level 2/3 support for internal and external end users for PC, server, and mainframe application problems- Interact with software vendors, Infrastructure services, and/or Applications Development to restore service and/or correct core problems.- Manage and coordinate the implementation of internal, external and off-the-shelf business applications with all IT and business groups.- Coordinate validation activities related to the deployment of business applications- Produce and assist training and communication programs.- Coordinate with internal and external service providers in the area of incident, problem, and change management, capacity planning and troubleshooting, representing the interests of supported business groups.- Support vendor contracts to established service level agreements.- Maintain knowledge of the IT industry, analyze the abilities of tools and technologies and compare with the needs of the business, recommend potential solutions to managers within the business. Show less



CTI Education Group

• South Africa
• Higher Education
• 300 - 400 Employee

• • Jan 2010 - Jun 2014

  - Lecturing (A+, N+, S+, Linux modules, Microsoft modules, Convergence+) - Student management - Maintain knowledge of the IT industry- Quality Assurance (Books, Exams)- Updated module content- Reports to sponsors- Fire Marshal activities

• • May 2009 - Jan 2010

  Managed campus network:- Account administration- Network Firewall and Proxy- Backup`s- Network Hardware