Reed has almost 25 years of SAS programming experience, including 16 years in the Biopharmaceutical industry. He has led, managed, and directed statistical programming, applications, and process improvement groups. He has experience with all manners of Phase I through Phase IV statistical programming support from safety to data management to biostatistics to regulatory to marketing and publications. This work includes writing coding tools, coding edit checks, building analysis datasets, writing code to produce statistical output for clinical reports, developing applications, writing standard policies and procedures, and building eSubmissions. He has knowledge of HL7, ICH, CDISC (SDTM and ADaM) standards and principles, and he has applied them to various projects. Reed holds a Bachelor’s Degree in Mathematics and a Master’s Degree in Liberal Arts.
Arvind has over 14 years of experience in Information Technology, including 12 years in the Biopharmaceutical industry. Arvind’s specialities are process improvement, quality management, and finding simple solutions for complex issues. He has extensive experience in all phases of the software development life cycle and implementation of clinical data management applications. He has led, trained, managed, and directed application development groups using various clinical applications. Arvind holds a Master’s Degree in Computer Science and a Bachelor’s Degree in Computer Science and Engineering.
Jeff has over 20 years SAS programming experience in the Biopharmaceutical industry. He has managed statistical programming groups and served as a principal SAS programmer in biotechnology companies and CROs. He has worked in a variety of therapeutic areas including oncology and endocrinology. He has experience with all manners of statistical programming support including data management, providing statistical output for clinical reports, and providing support and guidance for FDA submissions including knowledge of current CDISC (SDTM and ADaM) standards. Jeff holds a Master’s Degree in Biostatistics.
Carlo has over 25 years of experience in data management, application development, and statistical programming in the Biopharmaceutical industry. Carlo is versed in both Data Management and Biostatistical Programming, with expertise in process development and compliance. Carlo has served as a manager of CDMS technical staff, and as a Principal Statistical Programmer. In addition he has 14 years of consulting in the Biopharmaceutical industry, during the course of which he architected fit-for-purpose CDMS solutions, lead clinical and statistical programming initiatives, and provided BI solutions to clients.
Subbu has 17 years of experience in Information Technology, including 9 years in the Biopharmaceutical industry specializing in CDMS/EDC systems. Having worked with several leading EDC products, Subbu has expertise in the processes and implementation methodologies required to optimize these systems for clients needs and to integrate them with other functional areas. Subbu served as a lead on various EDC initiatives where he focused on implementation, vendor evaluation, developing standards, process development, validation, and deploying studies with CDISC standards. He also served as BI architect on clinical data warehouse. Subbu holds a Master’s Degree in Business Administration and Bachelor’s Degree in Computer Science.
