Sumitomo Pharma America, Inc.
Biotechnology • Pharmaceuticals • Healthcare Insurance
Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.
Associate Director, Statistical Programming
Job not on LinkedIn
October 8
Sumitomo Pharma America, Inc.
Biotechnology • Pharmaceuticals • Healthcare Insurance
Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.
📋 Description
• Lead on clinical studies and manage/provide training to team members when needed • Contribute and implement statistical analysis plans • Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments • Work closely with Biostatistics to create analysis specifications • Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer’s • Perform data analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS • Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate results • Help identify issues and initiates resolution of the problems • Act as a liaison between statistical programming, subcommittees and project teams
🎯 Requirements
• Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience • Strong SAS programming and Statistical background • FDA submission experience • Solid knowledge of CDISC standard (SDTM & ADaM) • BS/MS or equivalent in Statistics, Math or Scientific Discipline • Ability to demonstrate coaching skill to mentor Statistical Programmers • Solid knowledge of other software such as SpotFire, R Shinny is a plus
🏖️ Benefits
• eligibility for our 401(k) plan • medical, dental, vision, life and disability insurances • leaves provided in line with your work state • flexible paid time off • 11 paid holidays plus additional time off for a shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter
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