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Project Mgr III R&D Project/Program Mgmt

7-12 years

Bangalore / Bengaluru

1 vacancy

Project Mgr III R&D Project/Program Mgmt

Watson Pharama

posted 4hr ago

Job Description

  • 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.
Your experience and qualifications
  • 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.

Employment Type: Full Time, Permanent

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