- SDTM, ADAM, TLF.
- – Bachelor’s /Master’s degree with 6 to 10years, in physical science, data science, mathematics, statistics, computer science, or related discipline.
- SAS Certified with 6+ years full time using SAS
- Working knowledge of bio-pharmaceutical industry, specifically in the new drug development analytical / laboratory space
- Worked in GxP environment with deep understanding in regulations, and ALCOA principles
- Working knowledge of analytical laboratories
- In depth experience (6+ years) in using SAS for data derivation/transformation (SAS certified)
- Working experiences with different databases and source data formats
- Understanding of system development life cycle regulations
- Worked in a collaborative environment with team members
- Work collaboratively with team members on a daily base
- Participate in team meetings
- Independently work directly with Data Management Lead to gather requirements, including F2F/ video conferences
- Translate requirements to design, program and execute SAS codes to analyze, graph, derive and reporting analytical data for regulatory submissions
- Develop SAS edit checks for data cleaning/derivation
- Based on scientific and compliance principles in data derivation/transformation
- Extracting and merging data to generate standard CMC eCTD data tables, adhering to group standards
- Performing ad-hoc data reporting e.g. statistical analyses, metrics, plots
- Perform standard statistical analyses for shelf-life estimation
- Provide draft output within 24 hours for internal review
- Provide documentation of programs and projects adhering to regulatory and company standards
- Manage multiple projects with overlapping timelines and deliverables simultaneously
- Escalate issues to Project Lead directly and timely (within 1 day)
- Complete all required training timely
- Adhere to SOPs and GMP regulations
