Over 14+ years of professional clinical research experience with 6+ years in global clinical people/project management, currently working as Director of Statistical Programming on projects for Pharmaceutical, Biotech and CRO companies with various divisions of Clinical Research and Drug Development Operations that include primarily Statistical Programming, and also effectively liaising with other functional areas like CDM, Bio-Statistics, QA, Medical Writing, Regulatory Affairs,coupled with many years of prior experience as a Senior Statistical Programmer using SAS. Excellent knowledge and understanding of GCP, Code of Federal Regulations (21 CFR Part 11), ICH, FDA and various industry standards like CDISC, SDTM, ADaM and CDASH etc. and PMBOK project management standards.

Associate Director, Clinical Programming @ From 2015 to Present (less than a year)

Bachelor's degree (B.S) in Computer Science and Engineering @ Maharastra, India Ramakrishna Malneedi is skilled in: IT Management, Clinical Data Management, Bio-statistics, Pharmacovigilance, Medical Writing, EDC, SAS programming, CTMS, Regulatory Affairs, Clinical Project Management, Biostatistics, CRO, CDISC, GCP, Trial Management