Ephicacy - Senior Statistical Programmer

- Programming and validation of SDTM datasets including efficacy domains

- Thorough understanding of End- to-End SDTM process (CRF annotation- Define.xml)

- Experience in creating SDTM mapping specification preferred

- Annotate CRF's for data mapping of existing raw clinical data to CDISC (version 3.1.2, 3.2) compliant SDTM datasets

- Utilize Pinnacle 21 for verifying compliance of datasets with CDISC standards

- Experience in debugging system level macros and modifying them for study requirements

- Develop utility macros for reusability and efficiency

- Work on multiple projects according to priorities

- Experience with working on SDTM deliverables on multiple therapeutic areas and phases in clinical trials

- Role is primarily of an SDTM programmer, it is preferred the candidate has end to end knowledge including ADAM and TFLs

- Experience with CDSIC standards including CDASH or SDTM/ADaM

- Ability to work independently and as part of a team

- Being open to new learnings and sharing with team members

- Excellent communication skills [Written, Verbal, Interpersonal and organizational skills

- Proficient in using SAS Unix/Studio for programming

- Familiar with Unix environment and programming