Padmi

SAS Programmer

MumbaiPosted 2 months ago
Software engineeringSeniorFull Time; Regular
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REQUIRED SKILLS+ - SDTM, ADAM, TLF.EDUCATION+ Bachelors /Masters 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 SASEXPERIENCE AND SKILLFull 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 membersRESPONSIBILITIES+ 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 REQUIRED SKILLS+ - SDTM, ADAM, TLF.EDUCATION+ Bachelors /Masters 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 SASEXPERIENCE AND SKILLFull 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 membersRESPONSIBILITIES+ 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

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