Job Information
Exelixis Inc Senior Manager, Statistical & Clinical Programming in King of Prussia, Pennsylvania
Exelixis, Inc. seeks Senior Manager, Statistical & Clinical Programming in King of Prussia, PA.
Duties: Set goals and standards, identify and implement improvements, and resolve issues related to clinical trials data analysis. Perform the activities of a senior programmer and use SAS software to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests. Create analysis datasets, assess quality of data analysis programs, and develop automated analysis tools where appropriate. Define quality requirements and develop/implement quality practices, including SAS program validation procedures and documentation. Responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. Partner with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data. Define, develop and implement procedures, guidelines and policies for good programming practices and to achieve efficient, effective work flow.
Requires a Bachelor's degree in Computer Science, Information Systems, Biotechnology, or related discipline plus 9 years of related experience. In the alternative, employer will accept Master's degree in Computer Science, Information Systems, Biotechnology, or related discipline plus 7 years of related experience. Additionally, requires all of the following:
- 7 years of experience in:
- Adhering to FDA regulations regarding training records, guidelines, and SOPs;
- Advising on and producing programs and study datasets that meet CDISC standards; and
- CDISC SDTM and ADaM standards.
- 2 years of experience in:
- Training new employees and contractors on study specifics and departmental programming conventions and standards; and
- SAS programming.
Must also have authority to work permanently in the U.S. Applicants who are interested in this position may apply at www.jobpostingtoday.com Ref# 11951 for consideration.