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2012 CSL Behring L.L.C. - King of Prussia, PA
posted 2 months ago
About the position
The Senior Statistical Programmer at CSL Behring plays a crucial role in supporting clinical study teams by providing technical guidance and hands-on support. This hybrid position focuses on developing study outputs, including ADaM datasets, tables, figures, and listings, while ensuring the quality and accuracy of clinical data for regulatory submissions. The role involves collaboration with various departments to adhere to Standard Operating Procedures and improve processes within the Statistical Programming group.
Responsibilities
- Collaborate with peers and statisticians to ensure the quality and accuracy of clinical data for submission readiness.
- Lead efforts for pooled and exploratory analyses with the clinical programming team.
- Oversee the specification and delivery of ISS and ISE datasets and associated outputs when not provided by CRO.
- Design and implement complex SAS programs for reporting clinical trial data in CDISC ADaM format.
- Identify problems and develop global tools to enhance the efficiency of the Statistical Programming group.
- Perform additional statistical analyses to support regulatory agency responses and clinical trial reporting.
Requirements
- Bachelor's degree in Computer Science, Mathematics, or Statistics.
- At least 5 years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical environment using SAS Software.
- Understanding of clinical programming and statistical programming processes and standards.
- Experience with statistical programming using SAS, including the development and use of SAS Macros.
- Knowledge of CDISC standards (CDASH, SDTM, ADaM).
Benefits
- Medical
- Dental
- Vision
- 401K
- Paid time Off
