About the job
This role is part of the Clinical Analytics/Project Based Services department and will be based in Bangalore or remotely in India. • Primary responsibilities include ensuring the quality and timely execution of SDTM, ADaM/TFL artifacts for assigned studies. This involves developing and reviewing specifications (Defines) and creating/validating SAS programs for mapping raw datasets to CDISC SDTM, ADaM standards. The ideal candidate should have a graduate/post-graduate degree in Statistics or Biostatistics or Mathematics or Computer Science/Pharmacy with at least 6 years of experience in statistical programming. Proficiency in SDTM/ADaM/TLF is mandatory along with exposure to clinical trials pertaining to at least one Therapeutic area. The selected individual will lead a team and work on issues related to regulatory compliance within an integrated management system that includes ISO 9001, 27001, and other relevant standards.
Requirements
- Statistical programming
- SDTM
- ADaM
- Clinical trials
Qualifications
- Graduate/Post-graduate in Statistics or Biostatistics or Mathematics or Computer Science/Pharmacy
Preferred Technologies
- Statistical programming
- SDTM
- ADaM
- Clinical trials
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