Experience: 7-10years
Responsibilities:
1. Primarily responsible for quality and timely delivery of ADAM artifacts (ADAM Specifications, datasets) and TFLs
2. Programming and validation of ADAM safety datasets
3. Creation and validation of TFLs as per mock and SAP
4. Coordinate work on multiple projects according to priorities
5. Communicate with project team/stakeholders/ other departments and/or groups effectively.
Skillset:
1) Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials
2) Experience working with SQL/Macros
3) Experience with CDSIC standards including CDASH or SDTM/ADaM
4) Ability to work independently and as part of a team
5) Being open to new learnings and sharing with team members
6) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills]
7) Proficient in using SAS EG/Studio for programming
8) Familiar with Unix environment and programming
9) Prior experience in Oncology therapeutic area is preferred