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



*PAN and DOB are required for profile creation*