Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
Our client, a leading Life Sciences Company, needs to hire a Statistical Programmer to provide programming support for Phase 1 to Phase 3 studies, including project integration and disease monitoring project work.
- Responsibilities:
- Provides 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.
- 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.
Requirements:
- 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.
- Excellent organizational skills and ability to prioritize tasks.