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| Job Location | Chennai |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Management Consulting / Strategy |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Primary Responsibilities:This is Senior Manager level position for Statistical Programming. Key responsibilities and skills may include, but are not limited to:Programming edit checks for Data Management with SAS.Create tables, listings and figures for clinical study report.Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.Create or QC SDTM specifications and SDTM datasets.Create or QC ADaM specifications and ADaM datasets.Create or QC define.xml or define.pdfCreate Study Data Reviewer s Guide (cSDRG.pdf) and Analysis Data Reviewer s Guide (ADRG.pdf)Serve as team leader for one/more Programming groups.Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group.Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables.Following industry standards and be a mentor to other Programming leads or managers.Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.Be a role model for team members.Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminologyGood understanding of clinical drug development processDetail orientedStrong communication skills and coordination skills Good leadership skills,
Keyskills :
sassas programmingsdtmdata managementreportingstrong communication skillsrole modeldrug developmentclinical researchclinical practicescommunication skillsregulatory requirementsclinical study