Responsibilities:

Scope of Services: SDTM, ADaM, and TLF production and/or validation, Ad-hoc from statistics and/or other related programming requests and other statistical programming needs as requested by Company to support all clinical studies.
The person has deep understanding on data standard (e.g.,, CDISC SDTM, ADAM, Define.xml), as well as ICH and regulatory guidelines on data and reporting standards.
SDTM, ADaM, and TLF production and/or validation alignment of processes and procedures across partner functions and key stakeholders.

Requirements:

Bachelor's degree is required, Master's degree in Statistics, Mathematics, Computer Science, Computer Information Systems or Public Health is preferred.
5+ years of SAS programming experience in pharmaceutical or CRO environments.
In-depth knowledge of CDISC SDTM, ADaM.
Deep understanding of data dependencies, validation techniques.
Thorough knowledge of SAS is required.
Experience in R programming language and R Shiny app development is preferred.
Excellence in writing and communication.

Katalyst Healthcares and Life Sciences