Teva Project Mgr III R&D Project/Program Mgmt 

India, Karnataka, Bengaluru 

440312884

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.

• 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.

• Bachelor’s or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
• More than 7 years of professional experience in pharmaceutical or clinical research
• Excellent SAS knowledge of the following SAS modules/procedures: Base SAS; SAS report writing, SAS macros/functions.