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The opportunity
The Clinical Programming Manager is responsible to manage the timely and accurate execution of programming components of clinical trials. The Manager leads and manages completed projects, that involved global tasks or cross functional teams or outsourcing resources.  The role may require providing inputs to design and analysis and report the results of clinical trials including programming rules and mocked T/L/G; In addition, providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.
How you’ll spend your day
Being able to accomplish all the major duties of Senior SAS Programmer
Leading global projects with cross functional involvement and required project management and leadership capabilities
Supervise or mentor CROs or outsourcing programmers
Providing strong programming support to CDISC based e-submission.  Develop, review, and/or perform validation of generic macros.  Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets
Have good knowledge of understanding the statistical models in efficacy data analysis.
Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource issues
Core member of clinical team and main programming contact with the DM team, statistician and project physician.
Responsible for the standardization of Biometrics deliverables across study projects within an indication/therapeutic area.
Responsible for the overall definition of programming rules and standardization across therapeutic areas and/or indication.
Coordinating Clinical Programming resources, priorities and timelines with the clinical team
Participation in project team meetings.
Extending existing or developing new clinical programming methods to solve complex problems
Ensuring the accuracy and validity of data displays.
Ensuring the accuracy and validity of the study database (SDTM) and/or analysis database (ADaM), as applicable.
Primary responsible for all programming deliverables for NDA/MAA/IND/PSUR.
Work closely with Statistics group for the production of tables, listings and graphs as applicable.
Mentor and train selected associates within the Biometrics group for SAS programming.
Miscellaneous activities directed by management.