The Associate Director will be responsible for providing input into submission strategies and coordinate the Statistical Programming staff to maintain workflow for programming efficiency. The position will also serve the critical role in providing leadership to programming team/activities.
This Pharma organization is responsible for the development and commercialization of multiple drugs for the treatment of oncology and immunological diseases. The company is well-funded and rapidly growing in the pharma industry with patients across the globe to participate in their studies as part of their global development program.
- Be the Statistical Programming team study lead, focusing on data integrity, collaboration and on-time deliverables.
- Develop SAS code and table templates for preparing, processing and analyzing clinical data.
- Provide support in production of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.
- Manage assigned project programming activities to ensure timely delivery
- Use SAS programs to Write, test and validate statistical studies
- Provide high quality deliverables complies with contractual project requirements and SOPs
- Bachelors or master's degree with 7+ years of clinical research and programming experience using SAS, plus minimum 2 years of management experience
- Knowledge of SDTM, ADaM and CDISC methodologies
- Expert level SAS programming, Oncology Trials, FDA/EMEA trial and NDA/Regulatory submissions