Job Description
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
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