REQUIRED SKILLS
+ - SDTM, ADAM, TLF.

EDUCATION
+ – 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

EXPERIENCE AND SKILL
*Full time capacity in the following (minimal 5+ years, prefer with 6+years):*
+ 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

RESPONSIBILITIES
+ 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