Statistical Programmer Consultant
We are hiring a Statistical Programmer Consultant on a contract basis. This role will be remote based.
This is a W2 position.
The Consultant will provide timely support to the project team on all statistical programming matters according to the project strategy. Programs SDTM/ADaM/TLFs for the studies, write datasets specification, QC datasets and tables. Identifies and communicates changes in project requirements that may affect key deliverables.
Responsibilities
• Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs
• Creates and reviews annotated CRF to SDTM datasets
• Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives
• Functions as a positive role model for setting high expectations for quality, creativity and project ownership
• Works collaboratively with Clinical Operations, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
• Provides technical input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers)
• Works with Biometrics and other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
• Involved with the strategy for process improvement
• Identifies new tools to increase efficiency and quality
Qualifications
• Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline
• Minimum of 5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry
• Advanced SAS programming skill s and experience in other statistical software, such as R and S-Plus
• Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
• Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regards to statistical programming processes, management of statistical programming projects
• Excellent organizational skills and ability to prioritize tasks
We are hiring a Statistical Programmer Consultant on a contract basis. This role will be remote based.
This is a W2 position.
The Consultant will provide timely support to the project team on all statistical programming matters according to the project strategy. Programs SDTM/ADaM/TLFs for the studies, write datasets specification, QC datasets and tables. Identifies and communicates changes in project requirements that may affect key deliverables.
Responsibilities
• Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs
• Creates and reviews annotated CRF to SDTM datasets
• Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives
• Functions as a positive role model for setting high expectations for quality, creativity and project ownership
• Works collaboratively with Clinical Operations, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
• Provides technical input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers)
• Works with Biometrics and other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
• Involved with the strategy for process improvement
• Identifies new tools to increase efficiency and quality
Qualifications
• Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline
• Minimum of 5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry
• Advanced SAS programming skill s and experience in other statistical software, such as R and S-Plus
• Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
• Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regards to statistical programming processes, management of statistical programming projects
• Excellent organizational skills and ability to prioritize tasks
