The opportunity
The Clinical Programming Senior Manager is responsible to manage the timely and accurate execution of programming components of clinical trials.
The Senior 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
Essential Duties & Responsibilities:
Being able to accomplish all the major duties of Clinical Programming Manager.
Leading global projects with cross functional involvment 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 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 standartization 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 development 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)..
Primary responsible for all programming deliverables for NDA/MAA/IND/PSUR.
Work closely with Stataistics group for the production of tables, listings, and graphs as applicable.
Mentor and train selected associates within the Biometrics group for SAS programming; participation in project team meetings.
Miscellaneous activities directed by management.
