Statistical Programmer

Responsibilities

• Ensure all programming-related tasks are performed with high scientific and technical quality in compliance with SOP and policies
• Familiar with the systems used in the Biometric Division, such as the Clinical Data Repository. Also, CDISC standards, MedDRA, and WHODRUG Dictionaries
• Identify and participate in the development and implementation of new procedures and methodologies to increase the accuracy and efficiency of the programming processes
• Participate actively in meetings, discussions, knowledge sharing, and activities covering all aspects of clinical data programming

Tasks

• Collaborate with Clinical Data Managers and produce all required SDTM datasets.
• Generate ADaM datasets
• To work with Biostatisticians, by providing summaries and output for Phase I-IV clinical study reports, clinical trial registries, and integrated reports of efficacy and safety
• Perform Review/QC and documentation of the programming
• Assist in the development and QC of tools and programs implemented in the Biometric Division
• Perform role as Oversight Statistical Programmer for outsourced clinical trials

Qualifications:

• Degree in Statistics/Computer Science/Engineering or equivalent
• Relevant experience as a Statistical Programmer in Pharmaceutical related industry
• Statistical, analytical, or equivalent work experience preferred
• Excellent SAS Programming experience
• R programming experience will be an added advantage
• Strong analytical and problem-solving skills for the design, creation, and testing of programs
• Knowledge of CDSIC (Clinical Data Interchange Standards Consortium) in SDTM (Study Data Tabulation Model) and ADAM (Analysis Data Model)
• A solid team player, and at the same time able to work independently
• Good communication and coordination skills and ability to make decisions
• Fluent in written and spoken English