PiMARQ JD Code: 103
Role Name: Statistical programmers
Our Client has joined a historic alliance of 50 life sciences organizations that seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The DTRA plans to unite industry stakeholders, including healthcare companies, regulators, patient groups and research organizations with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized clinical research.
Experience: 4 to 9 years
Location- Bangalore
Job Specific Skills
- Mastery and train on generating tables, listings, and graphs from clinical trial databases using
SAS.
- Utilizes System Development Life Cycle (SDLC) for programming deliverables.
- Advanced user in SAS programming, SAS Base, and SAS Macros.
- Advanced knowledge of E-Submission Standards, Guidelines and Regulations.
- Mastery and train on SDTM standards including ability to write specifications.
- Advanced knowledge of ADaM standards including supporting specification writing.
- Proficient with MS Office applications.
- Advance knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements.
- Advanced experience with pooling of data sets for submissions.
- Advanced experience with BIMO outputs, define.xml, Reviewer’s Guides, SDSP.
- Lead study or small programming project teams.
Must Have:
- Specifically looking at people who have experience in Adams and TLF’s